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JAS Diagnostics Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2656-2017Class IIDrew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL April 21, 2017
Z-0827-2015Class IIGlucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serOctober 23, 2014
Z-1873-2014Class IIGlucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.April 7, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K130915XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACKMay 15, 2014
K080623CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NANovember 17, 2008
K080618DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUIDMay 23, 2008
K022519LDL CHOLESTEROL (AUTOMATED)September 30, 2002
K021671JAS HDL CHOLESTEROL (AUTOMATED) REAGENTJuly 19, 2002
K020454CHEMISTRY CALIBRATORApril 8, 2002
K020282JAS AMYLASE LIQUID REAGENTFebruary 28, 2002
K013912CREATINE KINASE (CK-NAC)January 18, 2002
K013698AST (SGOT)December 21, 2001
K012332JAS CARBON DIOXIDE LIQUID REAGENTSeptember 6, 2001
K012038JAS URIC ACID LIQUID REAGENTAugust 21, 2001
K011900GLUCOSE (HEXOKINASE)July 31, 2001
K011599ALKALINE PHOSPHATASE LIQUID REAGENTJuly 20, 2001
K011441JAS CALCIUM (ARSENAZO) REAGENTJuly 9, 2001
K003835JAS MAGNESIUM REAGENTMarch 23, 2001
K003912PHOSPHORUS REAGENTFebruary 21, 2001
K003829TOTAL BILIRUBINFebruary 12, 2001
K003693DIRECT BILIRUBINJanuary 29, 2001
K003247CREATININEDecember 14, 2000
K003327ALBUMINDecember 5, 2000