K222635 is an FDA 510(k) clearance for the Premier Resolution System. This device is classified as a Abnormal Hemoglobin Quantitation (Class II - Special Controls, product code GKA).
Submitted by Trinity Biotech (Primus Corporation, Dba Trinity Biotech) (Kansas City, US). The FDA issued a Cleared decision on August 4, 2023, 338 days after receiving the submission on August 31, 2022.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7415.
| 510(k) Number | K222635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2022 |
| Decision Date | August 04, 2023 |
| Days to Decision | 338 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKA - Abnormal Hemoglobin Quantitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7415 |