The following data is part of a premarket notification filed by Hitachi Chemical Diagnostics, Inc. with the FDA for Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test Reagent Cartridge Ast.
| Device ID | K120945 |
| 510k Number | K120945 |
| Device Name: | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| Applicant | HITACHI CHEMICAL DIAGNOSTICS, INC. 630 CLYDE CT. Mountain View, CA 94043 |
| Contact | Charles Tsou |
| Correspondent | Charles Tsou HITACHI CHEMICAL DIAGNOSTICS, INC. 630 CLYDE CT. Mountain View, CA 94043 |
| Product Code | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-29 |
| Decision Date | 2013-06-07 |
| Summary: | summary |