K823829 is an FDA 510(k) clearance for the FERRITIN IMMUNORADIOMETRIC ASSAY KIT. This device is classified as a Alpha-1-antitrypsin, Rhodamine, Antigen, Antiserum, Control (Class II - Special Controls, product code DFB).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on March 11, 1983, 81 days after receiving the submission on December 20, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5130.
| 510(k) Number | K823829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1982 |
| Decision Date | March 11, 1983 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DFB — Alpha-1-antitrypsin, Rhodamine, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5130 |