FDA 510(k) Applications Submitted by HEMAGEN DIAGNOSTICS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K041009 04/19/2004 RAICHEM CALCIUM (OCPC) LIQUID REAGENT HEMAGEN DIAGNOSTICS, INC.
K041051 04/19/2004 RAICHEM BUN RATE REAGENT (LIQUID) HEMAGEN DIAGNOSTICS, INC.
K041052 04/19/2004 RAICHEM GLUCOSE UV (LIQUID) HEMAGEN DIAGNOSTICS, INC.
K031101 04/07/2003 RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 HEMAGEN DIAGNOSTICS, INC.
K010864 03/22/2001 ANALYST PANELS + ANALYTICAL TEST ROTOR HEMAGEN DIAGNOSTICS, INC.
K011126 04/13/2001 RAICHEM CREATININE URINE STANDARD HEMAGEN DIAGNOSTICS, INC.
K021194 04/15/2002 RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM HEMAGEN DIAGNOSTICS, INC.
K022049 06/24/2002 MODIFICATION TO RAICHEM CALCIUM REAGENT HEMAGEN DIAGNOSTICS, INC.
K012250 07/17/2001 RAICHEM MULTI-ANALYTE CALIBRATOR HEMAGEN DIAGNOSTICS, INC.
K012649 08/13/2001 RAICHEM BUN RATE REAGENT HEMAGEN DIAGNOSTICS, INC.
K012668 08/13/2001 RAICHEM GLUCOSE UV REAGENT HEMAGEN DIAGNOSTICS, INC.
K022767 08/21/2002 RAICHEM LIPID CALIBRATOR HEMAGEN DIAGNOSTICS, INC.
K022772 08/21/2002 RAICHEM LDL-CHOLESTEROL DIRECT REAGENT HEMAGEN DIAGNOSTICS, INC.
K003012 09/26/2000 RAICHEM PHOSPORUS REAGENT HEMAGEN DIAGNOSTICS, INC.
K023784 11/12/2002 RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER HEMAGEN DIAGNOSTICS, INC.
K973823 10/07/1997 PR 3 ANTIBODY KIT HEMAGEN DIAGNOSTICS, INC.
K960324 01/23/1996 HEMAGEN CRP 150 KIT (EIA METHOD) HEMAGEN DIAGNOSTICS, INC.
K971039 03/21/1997 HEMAGEN ANTI CARDIOLIPIN SCREEN HEMAGEN DIAGNOSTICS, INC.
K971909 05/23/1997 VIRGO AMA ELISA KIT HEMAGEN DIAGNOSTICS, INC.
K962276 06/13/1996 HEMAGEN ENA DSDNA KIT (EIA METHOD) HEMAGEN DIAGNOSTICS, INC.
K992224 07/01/1999 VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT HEMAGEN DIAGNOSTICS, INC.
K992241 07/01/1999 VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT HEMAGEN DIAGNOSTICS, INC.
K992243 07/01/1999 VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT HEMAGEN DIAGNOSTICS, INC.
K962836 07/22/1996 HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) HEMAGEN DIAGNOSTICS, INC.
K972812 07/28/1997 RAICHEM PREALBUMIN SPIA HEMAGEN DIAGNOSTICS, INC.
K944438 09/12/1994 HEMAGEN CMV IGG KIT HEMAGEN DIAGNOSTICS, INC.
K973822 10/07/1997 VIRGO ANCA SCREEN KIT HEMAGEN DIAGNOSTICS, INC.
K973824 10/07/1997 VIRGO PANCO KIT HEMAGEN DIAGNOSTICS, INC.


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