Medical Device Manufacturer · US , Danville , CA

Kabi Diagnostica - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1990

Recent clearances: COACUTE ANTITHROMBIN CHROMOGENIC ASSAY, COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Kabi Diagnostica Hematology ✕

2 devices

1-2 of 2

Cleared Sep 25, 1990

COACUTE ANTITHROMBIN CHROMOGENIC ASSAY

Hematology · 118d

Cleared Jul 20, 1990

COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY

Hematology · 85d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Oct 21, 2026