K823087 is an FDA 510(k) clearance for the BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA. This device is classified as a Acid Phosphatase, Naphthyl Phosphate (Class II - Special Controls, product code CKB).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on November 18, 1982, 30 days after receiving the submission on October 19, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1020.
| 510(k) Number | K823087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1982 |
| Decision Date | November 18, 1982 |
| Days to Decision | 30 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 |