K091332 is an FDA 510(k) clearance for the AIA-PACK RBC FOLATE. This device is classified as a Acid, Folic, Radioimmunoassay (Class II - Special Controls, product code CGN).
Submitted by Tosoh Bioscience, Inc. (Grove City, US). The FDA issued a Cleared decision on October 2, 2009, 149 days after receiving the submission on May 6, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1295.
| 510(k) Number | K091332 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2009 |
| Decision Date | October 02, 2009 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CGN — Acid, Folic, Radioimmunoassay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1295 |