Hitachi Chemical Diagnostics, Inc. · Class I · Cleared Jun 7, 2013
| K-number | K120945 |
| Device name | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST |
| Applicant | Hitachi Chemical Diagnostics, Inc. |
| Product code | CKA |
| Device class | Class I |
| Decision date | Jun 7, 2013 |
| Decision | Substantially Equivalent |
| Regulation | 862.1030 |
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