K121232 is an FDA 510(k) clearance for the K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR. This device is classified as a Ferritin, Antigen, Antiserum, Control (Class II - Special Controls, product code DBF).
Submitted by Kamiya Biomedical Company (Tukwila, US). The FDA issued a Cleared decision on May 24, 2012, 30 days after receiving the submission on April 24, 2012.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K121232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2012 |
| Decision Date | May 24, 2012 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DBF - Ferritin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |