K092505 is an FDA 510(k) clearance for the BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203. This device is classified as a Ferritin, Antigen, Antiserum, Control (Class II - Special Controls, product code DBF).
Submitted by Beckman Coulter, Inc. (Co. Clare, IE). The FDA issued a Cleared decision on December 11, 2009, 119 days after receiving the submission on August 14, 2009.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K092505 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2009 |
| Decision Date | December 11, 2009 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DBF — Ferritin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |