K023991 is an FDA 510(k) clearance for the CHROMOCHECK ANTITHROMBIN 25. This device is classified as a Antithrombin Iii Quantitation (Class II - Special Controls, product code JBQ).
Submitted by Precision Biologic (Dartmouth, N.S., CA). The FDA issued a Cleared decision on April 28, 2003, 146 days after receiving the submission on December 3, 2002.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7060.
| 510(k) Number | K023991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2002 |
| Decision Date | April 28, 2003 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JBQ - Antithrombin Iii Quantitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7060 |