K043571 is an FDA 510(k) clearance for the CRYOCHECK CLOT S. This device is classified as a Test, Qualitative And Quantitative Factor Deficiency (Class II - Special Controls, product code GGP).
Submitted by Precision Biologic, Inc. (Dartmouth, N.S., CA). The FDA issued a Cleared decision on March 18, 2005, 81 days after receiving the submission on December 27, 2004.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.
| 510(k) Number | K043571 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2004 |
| Decision Date | March 18, 2005 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGP - Test, Qualitative And Quantitative Factor Deficiency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7290 |