K812596 is an FDA 510(k) clearance for the ULTRA ZYME PLUS ALP #64962, 65029 & 30. This device is classified as a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II - Special Controls, product code CJE).
Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on September 29, 1981, 18 days after receiving the submission on September 11, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K812596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1981 |
| Decision Date | September 29, 1981 |
| Days to Decision | 18 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 |