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Hemagen Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 52 products

Total Devices52
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K041051 RAICHEM BUN RATE REAGENT (LIQUID)CDQ2004-06-30 View
510(k) K041052 RAICHEM GLUCOSE UV (LIQUID)CFR2004-06-30 View
510(k) K041009 RAICHEM CALCIUM (OCPC) LIQUID REAGENTCIC2004-06-25 View
510(k) K031101 RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2JJY2003-06-16 View
510(k) K023784 RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERLBR2002-12-24 View
510(k) K022772 RAICHEM LDL-CHOLESTEROL DIRECT REAGENTMRR2002-09-17 View
510(k) K022767 RAICHEM LIPID CALIBRATORJIX2002-09-03 View
510(k) K021194 RAICHEM CRP HIGH SENSITIVITY TEST SYSTEMDCK2002-07-29 View
510(k) K022049 MODIFICATION TO RAICHEM CALCIUM REAGENTCJY2002-07-19 View
510(k) K012668 RAICHEM GLUCOSE UV REAGENTCFR2001-10-15 View
510(k) K012649 RAICHEM BUN RATE REAGENTCDQ2001-10-15 View
510(k) K012250 RAICHEM MULTI-ANALYTE CALIBRATORJIX2001-09-24 View
510(k) K010864 ANALYST PANELS + ANALYTICAL TEST ROTORKHS2001-05-21 View
510(k) K011126 RAICHEM CREATININE URINE STANDARDJIT2001-05-02 View
510(k) K003012 RAICHEM PHOSPORUS REAGENTCEO2000-10-25 View
510(k) K992241 VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KITMSV1999-08-30 View
510(k) K992243 VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KITMSV1999-08-30 View
510(k) K992224 VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KITMSV1999-08-30 View
510(k) K973822 VIRGO ANCA SCREEN KITMOB1997-11-13 View
510(k) K973823 PR 3 ANTIBODY KITMOB1997-11-13 View
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