K992851 is an FDA 510(k) clearance for the ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM. This device is classified as a Activated Whole Blood Clotting Time (Class II - Special Controls, product code JBP).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 14, 2000, 143 days after receiving the submission on August 24, 1999.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7140.
| 510(k) Number | K992851 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1999 |
| Decision Date | January 14, 2000 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JBP — Activated Whole Blood Clotting Time |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7140 |