K851377 is an FDA 510(k) clearance for the DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA. This device is classified as a Radioassay, Vitamin B12 (Class II - Special Controls, product code CDD).
Submitted by Diagnon Corp. (Laurel, US). The FDA issued a Cleared decision on August 21, 1985, 135 days after receiving the submission on April 8, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K851377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1985 |
| Decision Date | August 21, 1985 |
| Days to Decision | 135 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 |