K091283 is an FDA 510(k) clearance for the CAPILLARYS NEONAT HB (PN 2006). 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 February 22, 2010, 297 days after receiving the submission on May 1, 2009.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7415.
| 510(k) Number | K091283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2009 |
| Decision Date | February 22, 2010 |
| Days to Decision | 297 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 |