K851153 is an FDA 510(k) clearance for the COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE. This device is classified as a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA).
Submitted by Astral Medical Systems (Buena Park, US). The FDA issued a Cleared decision on November 5, 1985, 228 days after receiving the submission on March 22, 1985.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K851153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1985 |
| Decision Date | November 05, 1985 |
| Days to Decision | 228 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JPA — System, Multipurpose For In Vitro Coagulation Studies |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.5425 |