K100538 is an FDA 510(k) clearance for the TINA-QUANT FERRITIN GEN. 4. This device is classified as a Ferritin, Antigen, Antiserum, Control (Class II - Special Controls, product code DBF).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 22, 2010, 117 days after receiving the submission on February 25, 2010.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K100538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2010 |
| Decision Date | June 22, 2010 |
| Days to Decision | 117 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 |