K063823 is an FDA 510(k) clearance for the COAGUCHEK XS PT CONTROLS. This device is classified as a Plasma, Coagulation Control (Class II - Special Controls, product code GGN).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 29, 2007, 34 days after receiving the submission on December 26, 2006.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K063823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2006 |
| Decision Date | January 29, 2007 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGN — Plasma, Coagulation Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |