K955434 is an FDA 510(k) clearance for the ACCESS FOLATE ASSAY (MODIFICATION). 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 January 29, 1996, 119 days after receiving the submission on October 2, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1295.
| 510(k) Number | K955434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 1995 |
| Decision Date | January 29, 1996 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGN — Acid, Folic, Radioimmunoassay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1295 |