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Reagents Applications, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
63
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K982056RAICHEM CO2 REAGENTJune 24, 1998
K972853CHOLESTEROL RAPID LIQUID REAGENTSeptember 24, 1997
K922904RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND IIJuly 30, 1992
K915191RAI-TROL ELEVATED LIPIDS CONTROLDecember 18, 1991
K913398RAICHEM(TM) CREATINE KINASE-MB REAGENTSeptember 25, 1991
K911899RAICHEM SPIA C4 REAGENTMay 9, 1991
K911900RAICHEM SPIA C3 REAGENTMay 9, 1991
K911898RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENTMay 8, 1991
K905084RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UVDecember 20, 1990
K905085RAICHEM GGT REAGENTDecember 20, 1990
K904175RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENTNovember 13, 1990
K903123RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENTSeptember 14, 1990
K902593RAICHEM(TM) SPIA(TM) CRP REAGENTJune 28, 1990
K900875RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENTMarch 6, 1990
K896845RAICHEM(TM) UREA NITROGEN (COLOR) REAGENTFebruary 16, 1990
K896921RAICHEM TM HEMOGLOBIN CALIBRATORJanuary 25, 1990
K896922RAICHEM TM HEMOGLOBIN REAGENTJanuary 25, 1990
K894418RAICHEM(TM) SPIA(TM) IGA REAGENTSAugust 2, 1989
K894417RAICHEM(TM) SPIA(TM) IGM REAGENTSAugust 2, 1989
K894416RAICHEM(TM) SPIA(TM) IGG REAGENTSAugust 1, 1989