Chromogenix AB
FDA Regulatory Profile
Chromogenix AB appears in FDA public data with 0 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 23, 1996.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K963111 | COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S | December 23, 1996 |
| K952515 | COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY | January 23, 1996 |
| K952514 | COACUTE HEPARIN | November 20, 1995 |
| K922201 | COAMATE PROTEIN C CHROMOGENIC ASSAY | December 7, 1992 |