Medical Device Manufacturer · US , Mchenry , IL

Reagents Applications, Inc.

63 submissions · 63 cleared · Since 1980
63
Total
63
Cleared
0
Denied

Reagents Applications, Inc. — FDA 510(k) Submissions

Reagents Applications, Inc. has submitted 63 FDA 510(k) premarket notifications since 1980, of which 63 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides, Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes, Nad Reduction/nadh Oxidation, Lactate Dehydrogenase, Phosphomolybdate (colorimetric), Inorganic Phosphorus, Photometric Method, Magnesium . Use the specialty filter in the sidebar to narrow results.

63 devices
1–25 of 63
RAICHEM CO2 REAGENT
K982056 · KHS Enzymatic, Carbon-dioxide · Chemistry
Jun 1998 15d
CHOLESTEROL RAPID LIQUID REAGENT
K972853 · CHH Enzymatic... · Chemistry
Sep 1997 89d
RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II
K922904 · JJX Single (specified)... · Chemistry
Jul 1992 44d
RAI-TROL ELEVATED LIPIDS CONTROL
K915191 · JJY Multi-analyte Controls,... · Chemistry
Dec 1991 29d
RAICHEM(TM) CREATINE KINASE-MB REAGENT
K913398 · CGS Nad Reduction/nadh... · Chemistry
Sep 1991 57d
RAICHEM SPIA C4 REAGENT
K911899 · DBI Complement C4, Antigen,... · Immunology
May 1991 13d
RAICHEM SPIA C3 REAGENT
K911900 · CZW Complement C3, Antigen,... · Immunology
May 1991 13d
RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
K911898 · DAD Haptoglobin, Antigen,... · Immunology
May 1991 12d
RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV
K905084 · CGS Nad Reduction/nadh... · Chemistry
Dec 1990 36d
RAICHEM GGT REAGENT
K905085 · JQB Kinetic Method,... · Chemistry
Dec 1990 36d
RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT
K904175 · LKL Alpha-1-acid-glycoprotein... · Immunology
Nov 1990 63d
RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT
K903123 · JIQ Turbidimetric Method,... · Chemistry
Sep 1990 60d
RAICHEM(TM) SPIA(TM) CRP REAGENT
K902593 · DCN System, Test, C-reactive... · Immunology
Jun 1990 16d
RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT
K900875 · DDG Transferrin, Antigen,... · Chemistry
Mar 1990 8d
RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT
K896845 · CDL Berthelot Indophenol,... · Chemistry
Feb 1990 72d
RAICHEM TM HEMOGLOBIN CALIBRATOR
K896921 · KRZ Calibrator For Hemoglobin... · Hematology
Jan 1990 45d
RAICHEM TM HEMOGLOBIN REAGENT
K896922 · GKK Cyanomethemoglobin · Hematology
Jan 1990 45d
RAICHEM(TM) SPIA(TM) IGM REAGENTS
K894417 · DFT Igm, Antigen, Antiserum,... · Chemistry
Aug 1989 16d
RAICHEM(TM) SPIA(TM) IGA REAGENTS
K894418 · CZP Iga, Antigen, Antiserum,... · Chemistry
Aug 1989 16d
RAICHEM(TM) SPIA(TM) IGG REAGENTS
K894416 · KTO Reagent, Immunoassay, Igg · Chemistry
Aug 1989 15d
RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD
K883389 · JIW Calibrator, Surrogate · Chemistry
Dec 1988 126d
RAICHEM(TM) BILIRUBIN STANDARD
K882726 · JIS Calibrator, Primary · Chemistry
Aug 1988 59d
RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)
K880576 · CJY Azo Dye, Calcium · Chemistry
Jun 1988 121d
RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC
K880880 · JGJ Photometric Method,... · Chemistry
May 1988 86d
RAICHEM(TM) MAGNESIUM REAGENT
K874822 · JGJ Photometric Method,... · Chemistry
Jan 1988 58d
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