K902495 is an FDA 510(k) clearance for the ACID PHOSPHATASE REAGENT SET. This device is classified as a Acid Phosphatase, Naphthyl Phosphate (Class II - Special Controls, product code CKB).
Submitted by Tech Intl. Co. (Rochester Hills, US). The FDA issued a Cleared decision on July 16, 1990, 41 days after receiving the submission on June 5, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1020.
| 510(k) Number | K902495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 1990 |
| Decision Date | July 16, 1990 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CKB — Acid Phosphatase, Naphthyl Phosphate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1020 |