Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002806944

FEI Number

3002806944

Entity Name

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED

City/State/Country

LLANBERIS Wales, GB

Establishment Address

GLYN RHONWY, LLANBERIS Wales LL55 4EL, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIEMENS HEALTHCARE DIAGNOSTICS INC. (Owner Number: 9096044)

Owner / Operator Contact Address

Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue, Tarrytown, NY 10591, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202826

PMA Number

N/A

All Registered Proprietary Names

IMMULITE 2000 Cherry F242 IMMULITE 2000 Lamb F88 IMMULITE 2000 Trout F204 IMMULITE 2000 Turkey Meat F284 IMMULITE 2000 Chestnut F299 IMMULITE 2000 Cabbage F216 IMMULITE 2000 Pineapple F210 IMMULITE 2000 Lemon F208 IMMULITE 2000 Grapefruit F209 IMMULITE 2000 Watermelon F329 IMMULITE 2000 Pumpkin F225 IMMULITE 2000 Cheese, Mold Type F82 IMMULITE 2000 Spinach F214 IMMULITE 2000 Cucumber F244 IMMULITE 2000 Pear F94 IMMULITE 2000 Plum F255 IMMULITE 2000 Peach F95 IMMULITE 2000 Sweet Potato F54 IMMULITE 2000 Coffee F221 IMMULITE 2000 Grape F259 IMMULITE 2000 Sole F337 IMMULITE 2000 Chocolate F105 IMMULITE 2000 Broccoli F260 IMMULITE 2000 Red Snapper F381 IMMULITE 2000 Haddock F42 IMMULITE 2000 Lima Bean F182 IMMULITE 2000 Black Pepper F280 IMMULITE 2000 Avocado F96 IMMULITE 2000 Thyroid Uptake (TU) IMMULITE 2000 Blomia Tropicalis D20, 20 size IMMULITE 2000 Chicken Feathers E85, 20 size IMMULITE 2000 nDer p1 A310, 20 Size IMMULITE 2000 Brazilian Peppertree T401, 20 size IMMULITE 2000 nDer f2 A302, 20 size IMMULITE 2000 Penicillium Brevi-Compactum M305, 20 size IMMULITE 2000 nCan f 1 A174, 20 size IMMULITE 2000 nPen m 1, F351, 20 size IMMULITE 2000 Rabbit Bush W36, 20 size IMMULITE 2000 Turkey Feathers E89, 20 size IMMULITE 2000 Parrot Feathers E91, 20 size IMMULITE 2000 Pigeon Droppings E7, 20 size IMMULITE 2000 nDer f 1 A295, 20 size IMMULITE 2000 Aureobasidium Pullulans M12, 20 size IMMULITE 2000 nFel d 1 A345, 20 size IMMULITE 2000 nAsp r 1 A3050, 20 size IMMULITE 2000 Tobacco O201, 20 size IMMULITE 2000 Canary feather E201, 20 size IMMULITE 2000 Loblolly Pine T43, 20 size IMMULITE 2000 Budgerigar Feathers E78, 20 size IMMULITE 2000 nDer p 2 A316, 20 size IMMULITE IMMULITE 2000 OM-MA Sample Diluent (OV DIL) IMMULITE H.Pylori IgG Calibration Verification Material (HPG CVM) IMMULITE Rubella Quantitative IgG Calibration Verification Material (RUB CVM) IMMULITE Toxoplasma Quantitative IgG Calibration Verification Material (TXP CVM) Atellica IM aTPOII Diluent (aTPOII DIL) Atellica IM aTPOII Quality Control (aTPOII QC) Atellica IM aTPOII Master Curve Material (aTPOII MCM) ADVIA Centaur aTPOII Master Curve Material (aTPOII MCM) ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII) ADVIA Centaur aTPOII Diluent (aTPOII DIL) ADVIA Centaur aTPOII Quality Control (aTPOII QC) Atellica IM Anti-Thyroid Peroxidase II (aTPOII) IMMULITE 2000 Digoxin (DGX) IMMULITE 2000 GENTAMICIN IMMULITE 2000 IGF-I Sample Diluent (IGF DIL) IMMULITE 2000 IGF-1 (IGF) IMMULITE 2000 IGFBP-3 (BP3) IMMULITE 2000 IGF-1 Sample Diluent (IGF DIL) IMMULITE 2000 Growth Hormone (GRH) IMMULITE 2000 IGF-I (IGF) Third Generation TSH Control Module (TSH QC) IMMULITE 2000 Anti-TPO Ab Calibration Verification Material (ATA CVM) IMMULITE 2000 Thyroglobulin Calibration Verification Material (TG CVM) IMMULITE 2000 Anti-TG Ab Calibration Verification Material (ATG CVM) IMMULITE 2000 BR-MA Cinnamon (F220L2); Flounder (F147L2); Brewer's Yeast (F403L2); Cantaloupe (F102L2); Halibut (F303L2); Mushroom (F212L2) Green Bean (F315L2); Green Pepper (F263L2) IMMULITE 2000 3gAllergy Specific IgE Sugar Cane (F21L2); Yogurt (F360L2) Pinto Beans (F300L2); Red Kidney Bean (F287L2) IMMULITE 2000 LH (LH) IMMULITE 2000 Homocysteine Sample Diluent (HCY DIL) IMMULITE 2000 Homocysteine (HCY) IMMULITE 2000 Ferritin (FER) IMMULITE Calcitonin Calibration Verification Material (CAL CVM) IMMULITE Prostatic Acid Phosphatase Calibration Verification Material (PAP CVM) IMMULITE 2000 Beta-2 Microglobulin (BMG) IMMULITE Beta-2 Microglobulin Control Module (BMG QC) ACTH Control Module (ACT QC) IMMULITE 2000 Unconjugated Estriol IMMULITE Myoglobin CVM (MYO CVM) IMMULITE Albumin CVM (ALB CVM) IMMULITE 2000 Specific Allergens IMMULITE Third Generation TSH CVM (TSH CVM) IMMULITE DHEA-SO4 CVM (DHS CVM) IMMULITE Intact PTH CVM (iPT CVM) IMMULITE 2000 HCG (HCG) IMMULITE 2000 HCG Sample Diluent (HCG DIL) IMMULITE HCG Control Module (HCG QC) IMMULITE 2000 VALPROIC ACID (VAL) IMMULITE 2000 Androstenedione Calibration Verification Material (AND CVM) IMMULITE 2000 Troponin I Calibration Verification Material (TPI CVM) IMMULITE 2000 Gastrin (GAS) IMMULITE Rubella Quant IgG IMMULITE ADVIA Centaur HBc Total 2 (HBcT2) Atellica IM HBc Total 2 Quality Control (HBcT2 QC) Atellica IM HBc Total 2 (HBcT2) ADVIA Centaur HBc Total 2 Quality Control (HBcT2 QC) IMMULITE 2000 Specific Allergens IMMULITE 2000 3gAllergy Specific IgE IMMULITE 2000 Specific Allergens IMMULITE 2000 Rubella IgM (RUM) IMMULITE Rubella IgM Control Module (RUM QC) IMMULITE Pyrilinks-D Control Module (DPD QC) IMMULITE 2000 Pyrilinks-D (DPD) IMMULITE 2000 HCG Sample Diluent IMMULITE HCG Control Module IMMULITE/IMMULITE 1000 HCG Sample Diluent IMMULITE 2000 HCG IMMULITE/IMMULITE 1000 HCG HCG-Human chorionic gonadotropin IMMULITE 2000 ANTI-TPO IMMULITE 2000 Free T3 Calibration Verification Material (FT3 CVM) IMMULITE Gastrin Calibration Verification Material (GAS CVM) IMMULITE 2000 LH Calibrator Verification Material (LH CVM) IMMULITE® 2000 3gAllergyTM Specific IgE Universal Kit rMal d 4, (A796 Apple, Malus domestica) rBet v 2, (A127 Birch pollen, Betula verrucose) rPru av 1, (A597 Cherry, Prunus avium) rPru av 3, (A599 Cherry, Prunus avium) rPru av 4 (A600 Cherry, Prunus avium) n Pru p 3, (A603 Peach, Prunus persica) rMal d 1 (A464 Apple, Malus domestica) IMMULITE 2000 Theophylline (THE) IMMULITE 2000 Vancomycin Vancomycin IMMULITE 2000 Vancomycin Sample Diluent Unconjugated Estriol Calibration Verification Material (UE3 CVM) IMMULITE Syphilis Screen Control Module IMMULITE 2000 Syphilis Screen Cortisol Control Module IMMULITE SHBG Control Module (SBG QC) IMMULITE 2000 SHBG (SBG) IMMULITE 2000 Mixed Allergen Panels Oregano (F283), Parsley (F86), Pine Nut (F253), Vanilla (F234) 3gAllergy Specific Allergens: Basil (F269), Cacao (F93), IMMULITE 2000 HBsAg (HBS) IMMULITE 2000 HBsAg Confirmatory Total IgE Control Module IMMULITE Total IgE Control Module (TIE QC) IMMULITE Serum Drug Control Module IMMULITE 2000 Phenytoin (PHN) IMMULITE 2000 ACTH (ACT) IMMULITE 1000 Sycamore T11 (T11) IMMULITE 2000 L2SNC Specific IgE Negative Control IMMULITE 2000 3gAllergy Specific IgE (SPE) IMMULITE 2000 DC2L Specific IgE Positive Control IMMULITE 2000 Specific Allergens IMMULITE 2000 MC6L Specific IgE Positive Control IMMULITE 2000 DC1L Specific IgE Positive Control IMMULITE 2000 Prolactin (PRL) IMMULITE 2000 Prolactin Sample Diluent (PRL DIL) IMMULITE Homocysteine CVM (HCY CVM) IMMULITE Insulin CVM (INS CVM) IMMULITE Growth Hormone CVM (GRH CVM) IMMULITE HCG CVM (HCG CVM) IMMULITE 2000 Total Testosterone Calibrator Verification Material (TES CVM) IMMULITE 2000 C-Peptide Calibrator Verification Material (CPE CVM) IMMULITE 2000 SHBG Calibrator Verification Material (SBG CVM) IMMULITE 2000 Anti-CCP Calibration Verification Material (CCP CVM) IMMULITE 2000 Anti-CCP IgG (CCP) IMMULITE 2000 Multi-Diluent 2 ADVIA Centaur Multi-Diluent 3 (M-Dil 3) ADVIA Centaur Multi-Diluent 11 (M-Dil 11) Blood Gas Systems 600 Series Blood Gas ADVIA Centaur Multi-Diluent 15 IMMULITE 2000 IgG/IgM Sample Diluent Atellica IM Multi-Diluent 12 (M-Dil 12) Atellica IM Multi-Diluent 13 (M-Dil 13) Atellica IM Multi-Diluent 2 (M-Dil 2) Atellica IM Multi-Diluent 1 (M-Dil 1) Atellica IM Multi-Diluent 10 (M-Dil 10) Atellica IM Multi-Diluent 11 (M-Dil 11) Atellica IM Multi-Diluent 3 (M-Dil 3) Atellica IM Multi-Diluent 15 (M-Dil 15) ADVIA Centaur Multi-Diluent 10 (M-Dil 10) ADVIA Centaur Multi-Diluent 1 (M-Dil 1) Atellica HEMA Diluent (HEMA Diluent) IMMULITE 2000 Multi-Diluent 1 ADVIA Centaur Multi-Diluent 2 (M-Dil 2) MAGIC LITE INTACT PTH DILUENT IMMULITE Calcitonin Control Module (CAL QC) IMMULITE 2000 Calcitonin (CAL) IMMULITE 2000 Free PSA (fPS) IMMULITE 2000 Carcinoembryonic Antigen (CEA) IMMULITE 2000 Phenobarbital (PHE) IMMULITE 2000 Systems Diluent Tube Caps Atellica CH A-LYTE IMT Cleaner IMMUUTE 2000 Systems Microsampling Tubes IMMULITE 2000 Systems Allergen Tube Septum IMMULITE 2000 Systems Reaction Tubes IMMULITE 2000 Systems Diluent Tubes IMMULITE 2000 XPi System Sample Cup Nesting IMMULITE 2000 Chemiluminescent Substrate Module IMMULITE 2000 Systems Allergen Tube Caps IMMULITE 2000 Systems Microsampling Tube Caps IMMULITE 2000 XPi Immunoassay System IMMULITE 2000 Immunoassay System IMMULITE 2000 Herpes I & II IgG (HVG) IMMULITE PSA Calibration Verification Material (PSA CVM) IMMULITE 2000 OM-MA Calibration Verification Material (OV CVM) IMMULITE 2000 BR-MA Calibration Verification Material (BRM CVM) IMMULITE 2000 AFP Calibration Verification Material (AF CVM) IMMULITE 2000 Toxoplasma Quantitative IgG (TXP) IMMULITE Toxoplasma Quantitative IgG Control Module (TXP QC) IMMULITE IMMULITE 2000 Erythropoietin (EPO) IMMULITE/IMMULITE 1000 Erythropoietin (EPO) Sample Diluent IMMULITE EPO IMMULITE EPO Control Module IMMULITE 2000 Progesterone (PRG) IMMULITE 2000 T4 (TT4) Dimension T4 Flex IMMULITE 2000 C-Peptide Sample Diluent (PEP DIL) IMMULITE C- Peptide Control Module (CPE QC) IMMULITE 2000 Folic Acid (FOL) IMMULITE 2000 Folic Acid /Vitamin B12 Sample Diluent IMMULITE Ascorbic Acid (Ascorbic Acid) IMMULITE 2000 TSIIMMULITE 2000 TSI Calibration Verification Material (TSI CVM) IMMULITE IMMULITE 2000 CMV IgG IMMULITE/IMMULITE 1000 Free T4 IMMULITE 2000 OM-MA (OV) IMMULITE 2000 Myoglobin (MYO) Total IgE IMMULITE 2000 Total IgE IMMULITE 2000 Troponin I (TPI) IMMULITE 2000 Androstenedione (AND) IMMULITE 2000 C-Peptide (PEP) ADVIA Centaur C-peptide (CpS) Atellica IM C-peptide (CpS) IMMULITE 2000 Free T3 (FT3) IMMULITE 2000 Total Testosterone (TES) IMMULITE 2000 Free PSA Calibration Verification Material (Fps CVM) Progesterone Calibration Verification Material (CVM) IMMULITE 2000 TSH Sample Diluent (TSH DIL) IMMULITE 2000 Rapid TSH (RTH) IMMULITE High Sensitivity C-Reactive Protein Control Module (hsC QC) IMMULITE 2000 High Sensitivity C-Reactive Protein (hsC) IMMULITE 2000 High Sensitivity CRP (hsC) IMMULITE 2000 High Sensitivity C-Reactive Protein Sample Diluent (hsC DIL) IMMULITE 2000 DHEA-SO4 (DHS) IMMULITE 2000 Albumin (ALB) IMMULITE Albumin Control Module (ALB QC) IMMULITE 2000 Toxoplasma IgM (TXM) IMMULITE PAP Control Module IMMULITE 2000 PAP (PAP) IMMULITE 2000 PAP IMMULITE 2000 Mixed Allergen Panels IMMULITE 2000 Thyroglobulin Sample Diluent (TG DIL) IMMULITE 2000 Thyroglobulin (TG) IMMULITE 2000 3gAllergy Specific IgE (SPE CVM) IMMULITE 2000 Total IgE (TIE CVM) IMMULITE 2000 AFP (AF) IMMULITE 2000 AFP IMMULITE AFP Control Module IMMULITE 2000 PSA (PTS) IMMULITE 2000 Free T4 (F4) IMMULITE 2000 Systems Third Generation TSH IMMULITE Turbo CK-MB DOUBLE ANTIBODY ALBUMIN IMMULITE Thyroid Control Module IMMULITE PAP Control Module (PAP QC) Atellica IM aTgII Master Curve Material (aTgII MCM) ADVIA Centaur aTgII Quality Control (aTgII QC) Atellica IM Anti-Thyroglobulin II (aTgII) Atellica IM aTgII Quality Control (aTgII QC) ADVIA Centaur aTgII Master Curve Material (aTgII MCM) ADVIA Centaur Anti-Thyroglobulin II (aTgII) IMMULITE 2000 FSH (FSH) IMMULITE 2000 FSH Sample Diluent (FSH DIL) IMMULITE 2000 ACTH Calibrator Verification Material (ACT CVM) IMMULITE 2000 Thyroglobulin IMMULITE IMMULITE Thyroglobulin Sample Diluent IMMULITE Thyroglobulin IMMULITE Thyroglobulin Control Module IMMULITE Thyroglobulin Control Module (TG QC) F291 Cauliflower, F279 Chili Pepper, F50 Chub Mackerel Allergen - F237 Apricot, F261 Asparagus, F288 Blueberry F270 Ginger, F306 Lime, F65 Perch, F236 Whey IMMULITE 2000 Intact PTH (iPT) IMMULITE 2000 Intact PTH Sample Diluent (iPT DIL) IMMULITE Intact PTH Control Module (iPT QC) Atellica CH A-LYTE IMT Cleaner Dimension Vista® Acid Clean Flex® reagent cartridge IMMULITE 2000 Prolactin Calibrator Verification Material (PRL CVM) IMMULITE 2000 IGF-I Calibration Verification Material (IGF CVM) IMMULITE 2000 Free T4 Calibrator Verification Material (FT4 CVM) Cephalosporium acremonium Poplar Aspergillus niger Careless weed IMMULITE 2000 Allergens Sunflower Saltbush IMMULITE 2000 3gAllergy Specific IgE IMMULITE Probe Wash Module IMMULITE Probe Cleaning Kit IMMULITE 2000 / XPi Probe Cleaning Kit IMMULITE 2000 / XPi Probe Wash Module Atellica IM Thyroglobulin (Tg) Atellica IM Tg Master Curve Material (Tg MCM) IMMULITE 2000 Anti-HBc IgM (BcM) IMMULITE Vitamin B12 IMMULITE 2000 VITAMIN B12 IMMULITE 2000 Digitoxin (DGT) IMMULITE 2000 Cortisol (COR)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2009-11-05
CEE	Radioimmunoassay, Thyroxine-Binding Globulin	Clinical Chemistry	Class 2	862.1685	2006-12-15
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2011-04-04
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2005-05-12
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-08-20
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2025-12-12
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2025-12-12
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2025-12-12
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2003-03-03
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2005-05-12
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	2008-09-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-04-06
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-03-18
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2026-06-19
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2010-12-09
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2003-03-03
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2005-05-12
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2005-05-12
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Immunology	Class 2	866.5340	2003-03-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-02-26
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2003-03-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-03-25
CGI	Radioimmunoassay, Estriol	Clinical Chemistry	Class 1	862.1265	2005-05-12
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-01-14
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2009-05-28
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-03-05
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2005-05-12
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2005-05-12
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-02-26
CGC	Radioimmunoassay, Gastrin	Clinical Chemistry	Class 1	862.1325	2005-05-12
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2005-05-12
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2023-06-06
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2023-06-06
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2009-06-11
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2009-05-07
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2008-09-22
JMM	Column Chromatography & Color Development, Hydroxyproline	Clinical Chemistry	Class 1	862.1400	2005-05-12
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2011-03-25
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2008-09-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-11-11
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2022-07-18
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2003-03-03
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2011-03-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-01-09
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2010-01-04
CGR	Radioimmunoassay, Cortisol	Clinical Chemistry	Class 2	862.1205	2011-03-25
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2009-05-28
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2009-05-28
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2011-08-03
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	1999-09-02
JHR	Radioimmunoassay, Immunoglobulins (D, E)	Immunology	Class 2	866.5510	2009-12-10
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2005-05-12
CKG	Radioimmunoassay, Acth	Clinical Chemistry	Class 2	862.1025	2003-03-03
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2009-05-28
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2003-03-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-12-06
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-04-02
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-04-10
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2013-04-10
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	1998-02-12
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2005-05-12
JKR	Radioimmunoassay, Calcitonin	Clinical Chemistry	Class 2	862.1140	2005-05-12
MTG	Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions	Unknown	Class 3	N/A	2008-09-22
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2011-03-25
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2009-05-19
JHR	Radioimmunoassay, Immunoglobulins (D, E)	Immunology	Class 2	866.5510	2009-05-19
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2009-05-19
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2009-05-19
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2009-05-19
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2009-05-19
LGC	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	Microbiology	Class 2	866.3305	2005-05-12
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-08-28
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-02-26
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2005-05-12
GGT	Assay, Erythropoietin	Hematology	Class 2	864.7250	2005-05-12
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2005-05-12
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2018-02-20
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2003-03-03
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2005-05-12
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2016-03-03
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2005-05-12
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2005-05-12
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2023-09-29
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2005-05-12
JHR	Radioimmunoassay, Immunoglobulins (D, E)	Immunology	Class 2	866.5510	2011-03-25
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2005-05-12
CIZ	Radioimmunoassay, Androstenedione	Clinical Chemistry	Class 1	862.1075	2006-08-04
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2002-08-13
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2008-09-22
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2003-03-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-06-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-05-19
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2005-04-27
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2009-03-12
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2005-05-17
DFJ	Albumin, Rhodamine, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2026-04-15
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2008-09-22
JFH	Acid Phosphatase (Prostatic), Tartrate Inhibited	Clinical Chemistry	Class 2	862.1020	2003-03-03
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2009-05-28
MSW	System, Test, Thyroglobulin	Immunology	Class 2	866.6010	2005-05-12
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-12-06
LOK	Kit, Test, Alpha-Fetoprotein For Neural Tube Defects	Unknown	Class 3	N/A	2006-11-28
MTF	Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2005-05-12
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2005-05-12
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2018-01-25
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2018-01-25
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2011-03-25
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2006-08-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-04-06
JFH	Acid Phosphatase (Prostatic), Tartrate Inhibited	Clinical Chemistry	Class 2	862.1020	2026-04-21
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2026-01-06
JNL	Immunochemical, Thyroglobulin Autoantibody	Immunology	Class 2	866.5870	2026-01-06
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2026-01-06
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2003-03-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-02-26
MSW	System, Test, Thyroglobulin	Immunology	Class 2	866.6010	2003-03-03
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2011-05-17
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2009-07-02
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2001-08-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-05-07
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2009-08-11
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2009-05-19
MSW	System, Test, Thyroglobulin	Immunology	Class 2	866.6010	2025-09-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2025-09-03
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2008-09-22
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2008-09-22
LIG	Radioassay, Intrinsic Factor Blocking Antibody	Clinical Chemistry	Class 2	862.1810	2006-08-04
LFM	Enzyme Immunoassay, Digitoxin	Clinical Toxicology	Class 2	862.3300	2003-03-03
CGR	Radioimmunoassay, Cortisol	Clinical Chemistry	Class 2	862.1205	2021-02-10

Official Correspondent

No official correspondent registered.

US Agent Details

Mary Seeger Business: SIEMENS HEALTHCARE DIAGNOSTICS INC. Email: mary.seeger@siemens-healthineers.com Phone: (914) 3254329

Related Public Records

Same Entity

SIEMENS HEALTHCARE DIAGNOSTICS INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012817228	Epocal Inc	Ottawa Ontario, CA
3011194542	Siemens Healthcare GmbH	Berlin, DE
3009448641	Siemens Healthcare Diagnostics, Inc.	Mishawaka, IN, US
3004959793	EPOCAL, INC.	Ottawa Ontario, CA
9610633	SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD	SUDBURY Suffolk, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K874883	Incstar Corp.	WALNUT ALLERGEN DISC	1988-05-11
K935876	Bio-Rad Laboratories, Inc.	ACCESS SPECIFIC IGE ASSAY	1994-03-11
K093987	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6	2011-03-28
K132801	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY	2014-05-28
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941

Similar Registrations

Registration Number	Establishment Name	Location
3039353646	PHADIA AB	Uppsala, SE
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
9610566	PHADIA AB	UPPSALA, SE
3004973408	PHADIA US INC.	Portage, MI, US
2936856	Canon Medical Diagnostics USA, Inc.	MOUNTAIN VIEW, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002806944. Last updated year: 2026. Please use registration number 3002806944 when referencing this establishment in official correspondence.