K193556 is an FDA 510(k) clearance for the Cryocheck Hex LA. This device is classified as a Activated Partial Thromboplastin (Class II - Special Controls, product code GFO).
Submitted by Precision Biologic (Darmouth, CA). The FDA issued a Cleared decision on October 23, 2020, 305 days after receiving the submission on December 23, 2019.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7925.
| 510(k) Number | K193556 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2019 |
| Decision Date | October 23, 2020 |
| Days to Decision | 305 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GFO - Activated Partial Thromboplastin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7925 |