K823213 is an FDA 510(k) clearance for the DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI. This device is classified as a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II - Special Controls, product code CJE).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1982, 25 days after receiving the submission on October 28, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K823213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1982 |
| Decision Date | November 22, 1982 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1050 |