K955436 is an FDA 510(k) clearance for the ACCESS VITAMIN B12 ASSAY (MODIFICATION). This device is classified as a Radioassay, Vitamin B12 (Class II - Special Controls, product code CDD).
Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on January 24, 1996, 114 days after receiving the submission on October 2, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K955436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 1995 |
| Decision Date | January 24, 1996 |
| Days to Decision | 114 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 |