Medical Device Manufacturer · US , Mchenry , IL

Sorin Biomedica, Fiat, USA, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1980

Recent clearances: PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS, STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE, BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS

20

Total

20

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sorin Biomedica, Fiat, USA, Inc. Chemistry ✕

9 devices

1-9 of 9

Cleared Jun 25, 1984

ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT

Chemistry · 42d

Cleared Jun 25, 1984

TESTOSTERONE DIRECT RADIOIMMUNOASSAY

Chemistry · 42d

Cleared May 16, 1984

INSULIN RADIOIMMUNOASSAY KIT

Chemistry · 29d

Cleared Jan 11, 1984

DIRIA-PROGK IMMUNOASSAY

Chemistry · 154d

Cleared Dec 29, 1983

C. PTH RADIOIMMUNOASSAY KIT-CPTHK

Chemistry · 63d

Cleared May 13, 1983

CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK

Chemistry · 79d

Cleared Apr 21, 1980

Chemistry · 14d

Cleared Apr 21, 1980

Chemistry · 14d

Cleared Apr 21, 1980

Chemistry · 14d