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Hemagen Diagnostics, Inc.

52 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
RAICHEM BUN RATE REAGENT (LIQUID) (K041051)Hemagen Diagnostics, Inc.2004-06-30
RAICHEM GLUCOSE UV (LIQUID) (K041052)Hemagen Diagnostics, Inc.2004-06-30
RAICHEM CALCIUM (OCPC) LIQUID REAGENT (K041009)Hemagen Diagnostics, Inc.2004-06-25
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 (K031101)Hemagen Diagnostics, Inc.2003-06-16
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER (K023784)Hemagen Diagnostics, Inc.2002-12-24
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT (K022772)Hemagen Diagnostics, Inc.2002-09-17
RAICHEM LIPID CALIBRATOR (K022767)Hemagen Diagnostics, Inc.2002-09-03
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM (K021194)Hemagen Diagnostics, Inc.2002-07-29
MODIFICATION TO RAICHEM CALCIUM REAGENT (K022049)Hemagen Diagnostics, Inc.2002-07-19
RAICHEM GLUCOSE UV REAGENT (K012668)Hemagen Diagnostics, Inc.2001-10-15
RAICHEM BUN RATE REAGENT (K012649)Hemagen Diagnostics, Inc.2001-10-15
RAICHEM MULTI-ANALYTE CALIBRATOR (K012250)Hemagen Diagnostics, Inc.2001-09-24
ANALYST PANELS + ANALYTICAL TEST ROTOR (K010864)Hemagen Diagnostics, Inc.2001-05-21
RAICHEM CREATININE URINE STANDARD (K011126)Hemagen Diagnostics, Inc.2001-05-02
RAICHEM PHOSPORUS REAGENT (K003012)Hemagen Diagnostics, Inc.2000-10-25
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT (K992241)Hemagen Diagnostics, Inc.1999-08-30
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT (K992224)Hemagen Diagnostics, Inc.1999-08-30
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT (K992243)Hemagen Diagnostics, Inc.1999-08-30
VIRGO PANCO KIT (K973824)Hemagen Diagnostics, Inc.1997-11-13
PR 3 ANTIBODY KIT (K973823)Hemagen Diagnostics, Inc.1997-11-13
VIRGO ANCA SCREEN KIT (K973822)Hemagen Diagnostics, Inc.1997-11-13
RAICHEM PREALBUMIN SPIA (K972812)Hemagen Diagnostics, Inc.1997-08-28
VIRGO AMA ELISA KIT (K971909)Hemagen Diagnostics, Inc.1997-06-20
HEMAGEN ANTI CARDIOLIPIN SCREEN (K971039)Hemagen Diagnostics, Inc.1997-06-03
HEMAGEN CMV IGG KIT (K944438)Hemagen Diagnostics, Inc.1997-02-20
HEMAGEN ENA DSDNA KIT (EIA METHOD) (K962276)Hemagen Diagnostics, Inc.1996-12-05
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) (K962836)Hemagen Diagnostics, Inc.1996-09-12
HEMAGEN CRP 150 KIT (EIA METHOD) (K960324)Hemagen Diagnostics, Inc.1996-03-12
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) (K952077)Hemagen Diagnostics, Inc.1995-06-05
HEMAGEN ENA SCREENING KIT (EIA METHOD) (K952076)Hemagen Diagnostics, Inc.1995-06-05
HEMAGEN CHAGAS' KIT (EIA METHOD) (K930272)Hemagen Diagnostics, Inc.1995-05-19
HEMAGEN ENA SM/RMP KIT (EIA METHOD) (K950414)Hemagen Diagnostics, Inc.1995-03-29
HEMAGEN ENA SS-A KIT (EIA METHOD) (K946121)Hemagen Diagnostics, Inc.1995-02-22
HEMAGEN ENA SS-B KIT (EIA METHOD) (K946120)Hemagen Diagnostics, Inc.1995-02-22
HEMAGEN ENA JO-1 KIT (EIA METHOD) (K946124)Hemagen Diagnostics, Inc.1995-02-22
HEMAGEN ENA SM KIT (EIA METHOD) (K946123)Hemagen Diagnostics, Inc.1995-02-22
HEMAGEN ENA SCL-70 KIT (EIA METHOD) (K946122)Hemagen Diagnostics, Inc.1995-02-22
HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) (K944288)Hemagen Diagnostics, Inc.1994-10-03
HEMAGEN ACL IGA CALIBRATOR (K941840)Hemagen Diagnostics, Inc.1994-06-30
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) (K935828)Hemagen Diagnostics, Inc.1994-04-20
HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0 (K932373)Hemagen Diagnostics, Inc.1993-07-16
HEMAGEN ENA [JO-1] KIT (EIA METHOD) (K915420)Hemagen Diagnostics, Inc.1992-04-07
HEMAGEN ENA [RNP/SM] KIT (EIA METHOD) (K915272)Hemagen Diagnostics, Inc.1992-03-17
HEMAGEN ENA SCL-70 KIT (EIA METHOD) (K915282)Hemagen Diagnostics, Inc.1992-02-12
HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) (K915234)Hemagen Diagnostics, Inc.1991-12-20
HEMAGEN ENA SCREENING KIT (EIA METHOD) (K915058)Hemagen Diagnostics, Inc.1991-12-20
HEMAGEN ENA SCREENING KIT (K910232)Hemagen Diagnostics, Inc.1991-03-06
HEMAGEN ENA [JO-I] KIT (K902139)Hemagen Diagnostics, Inc.1990-05-18
SERATEST ENA [SSA] KIT (K900617)Hemagen Diagnostics, Inc.1990-02-23
SERATEST ENA [SCL-70] KIT (K894411)Hemagen Diagnostics, Inc.1989-08-02
SERATEST ENA [SS-B] KIT (K862700)Hemagen Diagnostics, Inc.1986-08-19
SERATEST RF (HEMAGGLUTINATION) KIT (K855221)Hemagen Diagnostics, Inc.1986-04-22

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