K941313 is an FDA 510(k) clearance for the STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET. This device is classified as a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE).
Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on May 17, 1994, 60 days after receiving the submission on March 18, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K941313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1994 |
| Decision Date | May 17, 1994 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1050 |