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Hemagen Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
52
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K041052RAICHEM GLUCOSE UV (LIQUID)June 30, 2004
K041051RAICHEM BUN RATE REAGENT (LIQUID)June 30, 2004
K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTJune 25, 2004
K031101RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2June 16, 2003
K023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERDecember 24, 2002
K022772RAICHEM LDL-CHOLESTEROL DIRECT REAGENTSeptember 17, 2002
K022767RAICHEM LIPID CALIBRATORSeptember 3, 2002
K021194RAICHEM CRP HIGH SENSITIVITY TEST SYSTEMJuly 29, 2002
K022049MODIFICATION TO RAICHEM CALCIUM REAGENTJuly 19, 2002
K012649RAICHEM BUN RATE REAGENTOctober 15, 2001
K012668RAICHEM GLUCOSE UV REAGENTOctober 15, 2001
K012250RAICHEM MULTI-ANALYTE CALIBRATORSeptember 24, 2001
K010864ANALYST PANELS + ANALYTICAL TEST ROTORMay 21, 2001
K011126RAICHEM CREATININE URINE STANDARDMay 2, 2001
K003012RAICHEM PHOSPORUS REAGENTOctober 25, 2000
K992224VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KITAugust 30, 1999
K992241VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KITAugust 30, 1999
K992243VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KITAugust 30, 1999
K973824VIRGO PANCO KITNovember 13, 1997
K973823PR 3 ANTIBODY KITNovember 13, 1997