K180762 is an FDA 510(k) clearance for the CAPI 3 HEMOGLOBIN(E). This device is classified as a Abnormal Hemoglobin Quantitation (Class II - Special Controls, product code GKA).
Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on December 14, 2018, 266 days after receiving the submission on March 23, 2018.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7415.
| 510(k) Number | K180762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2018 |
| Decision Date | December 14, 2018 |
| Days to Decision | 266 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 |