K053612 is an FDA 510(k) clearance for the DRI-STAT ACID PHOSPHATASE REAGENT. This device is classified as a Acid Phosphatase, Naphthyl Phosphate (Class II - Special Controls, product code CKB).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on April 26, 2006, 120 days after receiving the submission on December 27, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1020.
| 510(k) Number | K053612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2005 |
| Decision Date | April 26, 2006 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CKB — Acid Phosphatase, Naphthyl Phosphate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1020 |