K832711 is an FDA 510(k) clearance for the VITAMIN B12 FOLATE CA-1515-125. This device is classified as a Radioassay, Vitamin B12 (Class II - Special Controls, product code CDD).
Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983, 53 days after receiving the submission on August 12, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K832711 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1983 |
| Decision Date | October 04, 1983 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDD — Radioassay, Vitamin B12 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1810 |