K110413 is an FDA 510(k) clearance for the POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS. This device is classified as a Radioassay, Vitamin B12 (Class II - Special Controls, product code CDD).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on May 11, 2011, 86 days after receiving the submission on February 14, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K110413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2011 |
| Decision Date | May 11, 2011 |
| Days to Decision | 86 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 |