K161721 is an FDA 510(k) clearance for the Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set. This device is classified as a Radioassay, Vitamin B12 (Class II — Special Controls, product code CDD).
Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on September 20, 2016, 90 days after receiving the submission on June 22, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K161721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2016 |
| Decision Date | September 20, 2016 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CDD — Radioassay, Vitamin B12 |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1810 |