Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003593973

FEI Number

3003593973

Entity Name

Infrared Laboratory Systems dba SYNERMED

City/State/Country

WESTFIELD, IN, US

Establishment Address

17408 Tiller Ct Ste 1900, WESTFIELD, IN 46074, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Infrared Laboratory Systems, LLC (Owner Number: 10038715)

Owner / Operator Contact Address

17408 Tiller Court Suite 1900, Westfield, IN 46074, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K921025

PMA Number

N/A

All Registered Proprietary Names

VI410 Synermed GGT Reagent IR954 Synermed IR Cal II Multi Analyte Calibrator IR961-X Affirm 1 Multi Analyte Low Control IR962-X Affirm 2 Multi Analyte High Control UV085 AST Reagent IR170 Synermed Magnesium Reagent IR750 Direct Bilirubin Reagent UV185 ALT Reagent IR460 Synermed Uric Acid Reagent VI560 Synermed Creatinine Reagent Synermed IR500 Chemistry Analyzer IVD IR110 Synermed Phosphorus Reagent IR140 Synermed Triglycerides Reagent IR050 Synermed Chloride Reagent IR240 Synermed Calcium Reagent IR060 Synermed Cholesterol Reagent IR700 Total Bilirubin Reagent VI120 ALP-AMP Reagent DR-101-L Cellsolutions Density Reagent 1 Liter GCK-100-M CellSolutions Manual GluCyte Cytology Preparation Kit 100 tests and vials DR-101G CellSolutions Density Reagent 4x1 Liter GC-100E Cellsolutions GluCyte Cell Adherent 100mL GC1000E CellSolutions gluCyte Cell Adherent 1 Liter GCKI-500-M Cellsolutions Manual GluCyte Cytology Preparation Kit 500 tests GCKI-500-A CellSolutions Automated GluCyte Cytology Preparation Kit 500 tests GC-100NE Cellsolutions Manual GluCyte Cell Adherent 100mL GCI-25NE Cellsolutions Manual GluCyte Cell Sdherent 25mL GC-25NE CellSolutions Manual GluCyte Cell Adherent 25mL SS-250 Slideslick Glass Slide Cleaner GCI-100ANE CellSolutions Automated GluCyte Cell Adherent 100mL GCK-500-M CellSolutions Manual GluCyte Cytology Preparation Kit 500 tests GCI-100NE CellSolutions Manual GluCyte Cell Adherent 100mL GCK-500-A CellSolutions Automated GluCyte Cytology Preparation Kit 500 tests GCI-100E CellSolutions GluCyte Cell Adherent 100mL GCKI-100-M CellSolutions Manual GluCyte Cytology Preparation Kit 100 tests and vials GPR-0001 Synermed Negative DAU Calibrator IR150 Synermed UIBC Reagent UV190 Synermed Urea Nitrogen (BUN) Reagent ISE820 Synermed Olympus KCL 1 M Solution ISE810 Synermed Olympus ISE Mid Standard ISE800 Synermed Olympus ISE Buffer IR059 Synermed LDL-Cholesterol Reagent IR040 Synermed Calcium Reagent IR200 Automated Clinical Chemistry Analyzer IVD VI114 Synermed Sodium Reagent IR320 Synermed Serum Iron Reagent VI113 Synermed Potassium Reagent Synermed IR-1200 Automated Clinical Chemistry Analyzer IVD ISE720 Synermed Hitachi ISE Diluent ISE710 Synermed Hitachi ISE Internal Reference ISE730 Synermed Hitachi KCL 1 M Solution IR056 Synermed HDL-Cholesterol Reagent UV340 Synermed LDH Reagent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2011-11-04
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-10-27
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2011-11-04
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2011-11-04
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2011-11-04
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2011-11-04
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2011-11-04
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2011-11-04
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2011-11-04
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2011-11-04
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2011-11-04
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2011-11-04
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2011-11-04
JIQ	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2011-11-04
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2011-11-04
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2011-11-04
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2011-11-04
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2011-11-04
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2011-11-04
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2011-11-04
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2011-11-04
CHG	Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride	Clinical Chemistry	Class 2	862.1170	2011-11-04
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2011-11-04
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2011-11-04
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2011-11-04
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2011-11-04
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2015-05-11
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2016-09-19
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2016-09-19
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2011-11-04
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2011-11-04
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2011-11-04
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2011-11-04
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2011-11-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-09-19
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2016-09-19
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2011-11-04
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2011-11-04
MZU	System, Test, Sodium, Enzymatic Method	Clinical Chemistry	Class 2	862.1665	2016-09-19
CFM	Bathophenanthroline, Colorimetry, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2011-11-04
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-09-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-09-19
MZV	Test, System, Potassium, Enzymatic Method	Clinical Chemistry	Class 2	862.1600	2016-09-19
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-06-09
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2023-06-09
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2014-10-27
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2014-10-27
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2014-10-27
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-09-19
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2016-09-19
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2011-11-04

Official Correspondent

Ulyana Koshelap

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Infrared Laboratory Systems, 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
K041905	Instrumentation Laboratory CO	HEMOSIL CALIBRATION PLASMA	2004-09-28
K081103	Siemens Healthcare Diagnostics, Inc.	LOCI THYROID CALIBRATOR WITH MODEL RC610	2008-05-23
K852783	Advanced Biomedical Methods, Inc.	SGOT/ALT REAGENT	1985-07-22
K881300	Medical Analysis Systems, Inc.	MAGNESIUM LIQUID STABLE REAGENT SET	1988-05-17
K162399	Siemens Healthcare Diagnostics, Inc.	Atellica CH Magnesium (Mg)	2017-01-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Z-0006-2015	ELITech Clinical Systems SAS Zone lndustrielle SEES France	2	ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
Z-0012-2009	Roche Diagnostics Corp.	2	Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the qualitative determination of NAPA in serum or plasma.
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000
Z-2165-2011	Instrumentation Laboratory Co.	2	Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003593973. Last updated year: 2026. Please use registration number 3003593973 when referencing this establishment in official correspondence.