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 Cartridges For Ld And Amy.
| Device ID | K130685 |
| 510k Number | K130685 |
| Device Name: | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY |
| Classification | Catalytic Methods, Amylase |
| Applicant | HITACHI CHEMICAL DIAGNOSTICS, INC. 575 Shirlynn Court Los Altos, CA 94022 |
| Contact | Erika Ammirati |
| Correspondent | Erika Ammirati HITACHI CHEMICAL DIAGNOSTICS, INC. 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-13 |
| Decision Date | 2013-08-09 |
| Summary: | summary |