K060284 is an FDA 510(k) clearance for the CRYOCHECK CLOT APCR. This device is classified as a Test, Time, Partial Thromboplastin (Class II - Special Controls, product code GGW).
Submitted by Precision Biologic, Inc. (Dartmouth, N.S., CA). The FDA issued a Cleared decision on May 10, 2006, 96 days after receiving the submission on February 3, 2006.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7925.
| 510(k) Number | K060284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2006 |
| Decision Date | May 10, 2006 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGW - Test, Time, Partial Thromboplastin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7925 |