Medical Device Manufacturer · US , Concord , CA

Microgenics Corp. - FDA 510(k) Cleared Devices

107 submissions · 106 cleared · Since 1985

107

Total

106

Cleared

1

Denied

40 devices

26-40 of 40

Cleared Apr 26, 1994

CEDIA T4 MAB ASSAY

Chemistry · 50d

Cleared Mar 03, 1994

CEDIA T4 MAB ASSAY MODIFICATION

Chemistry · 87d

Cleared Jun 16, 1992

CEDIA RED BLOOD CELL FOLATE REAGENT PACK

Chemistry · 69d

Cleared Jun 04, 1992

CEDIA FERRITIN ASSAY

Chemistry · 132d

Cleared Nov 20, 1990

CEDIA (R) VITAMIN B12/FOLATE ASSAY

Chemistry · 29d

Cleared Sep 27, 1990

CEDIA TOTAL T3 ASSAY

Chemistry · 21d

Cleared Apr 03, 1990

CEDIA (TM) CORTISOL ASSAY

Chemistry · 14d

Cleared Dec 12, 1989

MODIFIED CEDIA(TM) CORTISOL ASSAY

Chemistry · 33d

Cleared Oct 31, 1989

CEDIA CORTISOL ASSAY

Chemistry · 152d

Cleared Dec 09, 1988

MODIFIED CEDIA TOTAL T4 ASSAY

Chemistry · 32d

Cleared Dec 02, 1988

MODIFICATION OF THE CEDIA DIGOXIN ASSAY

Chemistry · 67d

Cleared Aug 28, 1987

CEDIA DIGOXIN CR ASSAY

Chemistry · 59d

Cleared Aug 21, 1987

CEDIA(TM) T UPTAKE

Chemistry · 59d

Cleared Mar 25, 1986

CEDIA DIGOXIN ASSAY

Chemistry · 126d

Cleared Jul 22, 1985

CEDIA TOTAL T4 ASSAY

Chemistry · 63d