The following data is part of a premarket notification filed by Hitachi Chemical Diagnostics, Inc. with the FDA for Hitachi Clinical Analyzer S Test Regent Cartridge C-reactive Protein (crp).
| Device ID | K113809 |
| 510k Number | K113809 |
| Device Name: | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) |
| Classification | System, Test, C-reactive Protein |
| Applicant | HITACHI CHEMICAL DIAGNOSTICS, INC. 575 Shirlynn Court Los Altos, CA 94022 |
| Contact | Ericka B Ammirati |
| Correspondent | Ericka B Ammirati HITACHI CHEMICAL DIAGNOSTICS, INC. 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-23 |
| Decision Date | 2012-08-17 |
| Summary: | summary |