K952560 is an FDA 510(k) clearance for the SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER. This device is classified as a System, Multipurpose For In Vitro Coagulation Studies (Class II - Special Controls, product code JPA).
Submitted by Sienco, Inc. (Broomfield, US). The FDA issued a Cleared decision on September 5, 1995, 95 days after receiving the submission on June 2, 1995.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K952560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1995 |
| Decision Date | September 05, 1995 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JPA - System, Multipurpose For In Vitro Coagulation Studies |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |