K130141 is an FDA 510(k) clearance for the S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE). This device is classified as a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II - Special Controls, product code CJE).
Submitted by Hitachi Chemical Diagnostics, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 22, 2013, 59 days after receiving the submission on January 22, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K130141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2013 |
| Decision Date | March 22, 2013 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CJE - Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1050 |