Chromogenix AB is one of 59 FDA 510(k) medical device manufacturers from Sweden in the dataset, ranked by real submission volume.
Chromogenix AB - FDA 510(k) Cleared Devices
4
Total
4
Cleared
0
Denied
Chromogenix AB has 4 FDA 510(k) cleared medical devices. Based in Molndal, SE.
Historical record: 4 cleared submissions from 1992 to 1996. Primary specialty: Hematology.
Browse the FDA 510(k) cleared devices submitted by Chromogenix AB Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Chromogenix AB
4 devices
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