K051327 is an FDA 510(k) clearance for the ABBOTT AXSYM B12. This device is classified as a Radioassay, Vitamin B12 (Class II - Special Controls, product code CDD).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 3, 2005, 75 days after receiving the submission on May 20, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K051327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2005 |
| Decision Date | August 03, 2005 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| 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 |