K232027 is an FDA 510(k) clearance for the CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument. 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 April 4, 2024, 272 days after receiving the submission on July 7, 2023.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7415.
| 510(k) Number | K232027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2023 |
| Decision Date | April 04, 2024 |
| Days to Decision | 272 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 |