K051292 is an FDA 510(k) clearance for the ELECSYS RBC FOLATE HEMOLYZED REAGENT. This device is classified as a Acid, Folic, Radioimmunoassay (Class II - Special Controls, product code CGN).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 17, 2005, 30 days after receiving the submission on May 18, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1295.
| 510(k) Number | K051292 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2005 |
| Decision Date | June 17, 2005 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGN — Acid, Folic, Radioimmunoassay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1295 |