Medical Device Manufacturer · US , Medfield , MA

Chiron Diagnostics Corp. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1997

Recent clearances: CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY, CHIRON DIAGNOSTICS ACS: 180 FOLATE, CHIRON DIAGNOSTICS ACS: 180 FT3

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Chiron Diagnostics Corp. Immunology ✕

7 devices

1-7 of 7

Cleared Aug 05, 1999

CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY

Immunology · 41d

Cleared Jun 30, 1999

CHIRON DIAGNOSTICS ACS: 180 FOLATE

Immunology · 54d

Cleared Oct 15, 1998

CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY

Immunology · 76d

Cleared Aug 12, 1998

ACS:CENTAUR CEA

Immunology · 110d

Cleared Aug 12, 1998

ACS:CENTAUR PSA2 IMMUNOASSAY

Immunology · 78d

Cleared Jul 07, 1998

ACS:CENTAUR AFP

Immunology · 64d

Cleared Aug 08, 1997

ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER...

Immunology · 164d