K820975 is an FDA 510(k) clearance for the GILCHEM ACID PHOSPHATASE REAGENT. This device is classified as a Acid Phosphatase, Naphthyl Phosphate (Class II - Special Controls, product code CKB).
Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on April 26, 1982, 20 days after receiving the submission on April 6, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1020.
| 510(k) Number | K820975 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1982 |
| Decision Date | April 26, 1982 |
| Days to Decision | 20 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 |