K822728 is an FDA 510(k) clearance for the SOLID PHASE SIMUL TRAC VITAMIN B12. This device is classified as a Acid, Folic, Radioimmunoassay (Class II - Special Controls, product code CGN).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on November 5, 1982, 58 days after receiving the submission on September 8, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1295.
| 510(k) Number | K822728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 1982 |
| Decision Date | November 05, 1982 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGN — Acid, Folic, Radioimmunoassay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1295 |