K780557 is an FDA 510(k) clearance for the FOLATE REAGENT KIT, ARIA-II SYSTEM. This device is classified as a Acid, Folic, Radioimmunoassay (Class II - Special Controls, product code CGN).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on May 18, 1978, 43 days after receiving the submission on April 5, 1978.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1295.
| 510(k) Number | K780557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 1978 |
| Decision Date | May 18, 1978 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | CGN — Acid, Folic, Radioimmunoassay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1295 |