Medical Device Manufacturer · SE , Molndal

Chromogenix AB - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1992

Recent clearances: COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S, COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Chromogenix AB Hematology ✕

4 devices

1-4 of 4

Cleared Dec 23, 1996

COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S

Hematology · 133d

Cleared Jan 23, 1996

COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY

Hematology · 237d

Cleared Nov 20, 1995

COACUTE HEPARIN

Hematology · 173d

Cleared Dec 07, 1992

COAMATE PROTEIN C CHROMOGENIC ASSAY

Hematology · 210d