K943149 is an FDA 510(k) clearance for the ACCESS RED BLOOD CELL FOLATE ASSAY. This device is classified as a Acid, Folic, Radioimmunoassay (Class II - Special Controls, product code CGN).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on August 26, 1994, 57 days after receiving the submission on June 30, 1994.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1295.
| 510(k) Number | K943149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1994 |
| Decision Date | August 26, 1994 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CGN — Acid, Folic, Radioimmunoassay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1295 |