K943366 is an FDA 510(k) clearance for the IL TEST ACID PHOSPHATASE. This device is classified as a Acid Phosphatase, Naphthyl Phosphate (Class II - Special Controls, product code CKB).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on January 29, 1996, 565 days after receiving the submission on July 13, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1020.
| 510(k) Number | K943366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1994 |
| Decision Date | January 29, 1996 |
| Days to Decision | 565 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 |