K120945 is an FDA 510(k) clearance for the HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST. This device is classified as a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I - General Controls, product code CKA).
Submitted by Hitachi Chemical Diagnostics, Inc. (Mountain View, US). The FDA issued a Cleared decision on June 7, 2013, 435 days after receiving the submission on March 29, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1030.
| 510(k) Number | K120945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2012 |
| Decision Date | June 07, 2013 |
| Days to Decision | 435 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CKA - Nadh Oxidation/nad Reduction, Alt/sgpt |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1030 |