Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1063851

FEI Number

1000442352

Entity Name

MERCEDES MEDICAL LLC

City/State/Country

Lakewood Ranch, FL, US

Establishment Address

12210 Rangeland Parkway, Lakewood Ranch, FL 34211, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

MERCEDES MEDICAL LLC (Owner Number: 9033351)

Owner / Operator Contact Address

12210 Rangeland Parkway, --, Lakewood Ranch, FL 34211, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Radioimmunoassay, testosterones and dihydrotestosterone Galileo Series 2 Total T4 Biuret (colorimetric), Total Protein Butterfly Needle Ottix Plus; Access Wash Buffer II Photometric Method, Iron (non-heme) TSH Urine Transfer Straw BluWing Advanced Safety Butterfly 21g/23g/25g COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Safe Capsule; Sicura Lab Equipment Radioimmunoassay (two-site solid phase), ferritin GreenFix HIHG Capacity Section Dryer Tanner Polymer Patient Cassette Pipette Tip 1-200uL System, Test, Vitamin D / Calibrator, Secondary Culture Tube,13x100mm, 7mL, 250/BG Tube, False Bottom, 5mL, PP, 1000/CS Test Tube, 12x75mm, 5mL, 1000/BG Test Tube, 13x100mm, 8mL PS, 1000/BG Tube Screw Cap, False Bottom, White, 500 Test Tube, 12x75mm, 5mL, PP, 1000/BG Transport Tube, 10mL, PP, White, 100/BG Test Tube, 13x75mm, 5mL, PP, 1000/BG Test Tube, 13x75mm, 5mL, PS, 1000/BG Transport Tube, 10mL, PP White, 100/BG Culture Tube,12x75mm, 5mL, 250/BG Tanner Scientific Single Urine Specimen Collection Kit Cristallo Oral Swab, Nasopharyngeal Swab high profile blade holder; low profile blade holder SLEE SlideTec heat; SLEE Slidetec Water; SLEE Slidetec Water/Heat AllTest Fentanyl Urine Test Cassette (Home Test) BluTouch Nitrile Glove Safety Multi-Drawing Needle with/without holder Parafin56 Parafin58 Parafin53 Biopsy Bags Lipase hydrolysis/glycerol kinase enzyme, triglycerides Calibrator, Secondary / Ldl & Vldl Precipitationi, Cholesterol Via Esterase-Oxidase, Hdl Needle, hypodermic, single lumen; Syringe, piston; blood collection Single (Specified) Analyte Controls (Assayed And Unassayed) Mercuric Thiocyanate, Colorimetry, Chloride Urease and glutamic dehydrogenase, urea nitrogen Printec Autoloa Tanner Surgical Apparel Cooling Plate Manual Staining Set 12 Reservoirs, 450 ml; Tiziano None Tissue Processor Donatello Series 2 BluWing Advanced Starfrost; Tanner Scientific; Tanner Tape Nad Reduction/nadh Oxidation, Lactate Dehydrogenase Citoswab Collection and Transport Kit NADY Oxidation/Nad Reduction, ALT/SGPT Transition Reagent for Cristallo Cyto Brush 10% NBF Freezing Attachment Tissue Culture Dish Alkaline Picrate, Colorimetry, Creatinine Pipette Aquatec

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2024-11-01
IFB	Cytocentrifuge	Pathology	Class 1	864.3300	2025-09-17
IDO	Microtome, Rotary	Pathology	Class 1	864.3010	2017-12-15
KEY	Stainer, Tissue, Automated	Pathology	Class 1	864.3800	2019-12-10
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2024-01-08
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2024-01-08
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2024-01-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-03-13
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-03-13
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2019-02-11
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2024-01-08
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2024-01-08
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2024-01-08
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2019-07-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2022-05-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-05-03
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-03-30
KIM	Device For Sealing Microsections	Pathology	Class 1	864.3400	2025-09-17
LDY	Fixative, Formalin-Containing	Pathology	Class 1	864.4010	2019-02-11
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2005-05-26
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Immunology	Class 2	866.5340	2024-11-01
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2019-02-11
IDR	Ovens, Paraffin	Pathology	Class 1	864.3010	2022-07-18
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2005-05-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-12-12
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-12-12
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-12-12
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2019-12-10
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2017-12-27
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2024-11-01
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2024-11-01
KJG	Tube, Tissue Culture	Pathology	Class 1	864.3010	2017-08-30
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2017-12-29
LEB	Mounting Media	Pathology	Class 1	864.4010	2005-05-26
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-03-11
IDL	Microtome, Accessories	Pathology	Class 1	864.3010	2019-02-11
IEG	Table, Slide Warming	Pathology	Class 1	864.3010	2022-03-31
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2023-11-13
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2023-11-13
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-08-06
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-08-06
KEO	Formulations, Paraffin, All	Pathology	Class 1	864.4010	2023-12-12
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2018-09-26
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2024-11-01
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2024-01-08
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2025-05-12
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2025-05-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-09-19
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-09-19
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-09-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2025-05-12
CHJ	Mercuric Thiocyanate, Colorimetry, Chloride	Clinical Chemistry	Class 2	862.1170	2025-05-12
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2024-11-01
LJG	Quality Control Slides	Microbiology	Class 1	866.2660	2022-03-31
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2021-03-09
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2004-06-16
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-30
MXT	Device, Accessory, Cooling Plate For Tissue Embedding Station	Pathology	Class 1	864.3010	2018-02-16
KIO	Slide Stainer, Immersion Type	Pathology	Class 1	864.3800	2005-07-14
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2005-05-26
IEO	Processor, Tissue, Automated	Pathology	Class 1	864.3875	2018-02-16
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2021-04-09
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-04-09
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2005-07-14
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2024-01-08
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2021-01-07
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2024-11-01
KEM	Agent, Clearing	Pathology	Class 1	864.4010	2005-07-14
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2008-01-28
IFP	Formalin, Neutral Buffered	Pathology	Class 1	864.4010	2005-05-26
IDN	Microtome, Freezing Attachment	Pathology	Class 1	864.3010	2021-05-28
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2019-12-10
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2025-05-12
GJW	Pipette, Pasteur	Hematology	Class 1	864.6160	2005-05-26
IDY	Bath, Flotation, Tissue	Pathology	Class 1	864.3010	2021-10-25

Official Correspondent

Misty McWhorter

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MERCEDES MEDICAL LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080167	Siemens Healthcare Diagnostics	ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS	2008-08-08
K140859	Siemens Healthcare Diagnostics, Inc.	DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT	2014-11-26
K083373	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 FREE T4	2009-02-02
K861663	Data Medical Associates, Inc.	TOTAL PROTEIN PROCEDURE	1986-06-13
K832169	Sandare Chemical Co., Inc.	TOTAL PROTEIN PROCEDURE	1983-08-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2012	Richard-Allan Scientific Company	1	Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.
Z-0023-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Z-0033-2022	Sentinel CH SpA Via Robert Koch	2	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1063851. Last updated year: 2026. Please use registration number 1063851 when referencing this establishment in official correspondence.