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 Glucose (glu).
| Device ID | K120369 |
| 510k Number | K120369 |
| Device Name: | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) |
| Classification | Hexokinase, Glucose |
| Applicant | HITACHI CHEMICAL DIAGNOSTICS, INC. 630 CLYDE CT. Mountain View, CA 94043 |
| Contact | Bunichiro Nakajima |
| Correspondent | Bunichiro Nakajima HITACHI CHEMICAL DIAGNOSTICS, INC. 630 CLYDE CT. Mountain View, CA 94043 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-06 |
| Decision Date | 2012-05-10 |
| Summary: | summary |