K211485 is an FDA 510(k) clearance for the STA- NeoPTimal. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).
Submitted by Diagnostica Stago S.A.S (Asniéres Sur Seine, FR). The FDA issued a Cleared decision on December 23, 2022, 589 days after receiving the submission on May 13, 2021.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.
| 510(k) Number | K211485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2021 |
| Decision Date | December 23, 2022 |
| Days to Decision | 589 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GJS - Test, Time, Prothrombin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7750 |