K082227 is an FDA 510(k) clearance for the MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227. 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 March 26, 2009, 231 days after receiving the submission on August 7, 2008.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7415.
| 510(k) Number | K082227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2008 |
| Decision Date | March 26, 2009 |
| Days to Decision | 231 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 |