Hemagen Diagnostics, Inc. - FDA 510(k) Cleared Devices
52
Total
52
Cleared
0
Denied
52 devices
Cleared
Dec 05, 1996
HEMAGEN ENA DSDNA KIT (EIA METHOD)
Immunology
175d
Cleared
Sep 12, 1996
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
Immunology
52d
Cleared
Mar 12, 1996
HEMAGEN CRP 150 KIT (EIA METHOD)
Immunology
49d
Cleared
Jun 05, 1995
HEMAGEN ENA SCREENING KIT (EIA METHOD)
Immunology
33d
Cleared
Jun 05, 1995
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
Immunology
33d
Cleared
May 19, 1995
HEMAGEN CHAGAS' KIT (EIA METHOD)
Microbiology
850d
Cleared
Mar 29, 1995
HEMAGEN ENA SM/RMP KIT (EIA METHOD)
Immunology
57d
Cleared
Feb 22, 1995
HEMAGEN ENA SS-B KIT (EIA METHOD)
Immunology
69d
Cleared
Feb 22, 1995
HEMAGEN ENA SS-A KIT (EIA METHOD)
Immunology
69d
Cleared
Feb 22, 1995
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
Immunology
69d
Cleared
Feb 22, 1995
HEMAGEN ENA SM KIT (EIA METHOD)
Immunology
69d
Cleared
Feb 22, 1995
HEMAGEN ENA JO-1 KIT (EIA METHOD)
Immunology
69d
Cleared
Oct 03, 1994
HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)
Immunology
31d
Cleared
Jun 30, 1994
HEMAGEN ACL IGA CALIBRATOR
Immunology
78d
Cleared
Apr 20, 1994
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
Immunology
134d
Cleared
Jul 16, 1993
HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0
Immunology
60d
Cleared
Apr 07, 1992
HEMAGEN ENA [JO-1] KIT (EIA METHOD)
Immunology
127d
Cleared
Mar 17, 1992
HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
Immunology
113d
Cleared
Feb 12, 1992
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
Immunology
79d
Cleared
Dec 20, 1991
HEMAGEN ENA SCREENING KIT (EIA METHOD)
Immunology
42d
Cleared
Dec 20, 1991
HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)
Immunology
28d
Cleared
Mar 06, 1991
HEMAGEN ENA SCREENING KIT
Immunology
47d
Cleared
May 18, 1990
HEMAGEN ENA [JO-I] KIT
Immunology
9d
Cleared
Feb 23, 1990
SERATEST ENA [SSA] KIT
Immunology
15d
Cleared
Aug 02, 1989
SERATEST ENA [SCL-70] KIT
Immunology
16d