K060755 is an FDA 510(k) clearance for the ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK. This device is classified as a Radioassay, Vitamin B12 (Class II - Special Controls, product code CDD).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 10, 2006, 20 days after receiving the submission on March 21, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K060755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2006 |
| Decision Date | April 10, 2006 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDD — Radioassay, Vitamin B12 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1810 |