The following data is part of a premarket notification filed by Hitachi Chemical Diagnostics, Inc. with the FDA for S Test Reagent Cartridge Bun And S Test Reagent Cartridge Cre.
| Device ID | K132462 |
| 510k Number | K132462 |
| Device Name: | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE |
| Classification | Urease, Photometric, Urea Nitrogen |
| 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 | CDN |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-07 |
| Decision Date | 2013-10-28 |
| Summary: | summary |