K112491 is an FDA 510(k) clearance for the SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2. This device is classified as a Abnormal Hemoglobin Quantitation (Class II - Special Controls, product code GKA).
Submitted by Sebia (Evry, FR). The FDA issued a Cleared decision on May 24, 2012, 269 days after receiving the submission on August 29, 2011.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7415.
| 510(k) Number | K112491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2011 |
| Decision Date | May 24, 2012 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GKA — Abnormal Hemoglobin Quantitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7415 |