K212183 is an FDA 510(k) clearance for the STA R Max 3, STA Compact Max 3. This device is classified as a System, Multipurpose For In Vitro Coagulation Studies (Class II - Special Controls, product code JPA).
Submitted by Diagnostica Stago S.A.S (Asniéres Sur Seine, FR). The FDA issued a Cleared decision on June 7, 2023, 694 days after receiving the submission on July 13, 2021.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K212183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2021 |
| Decision Date | June 07, 2023 |
| Days to Decision | 694 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 |