The following data is part of a premarket notification filed by Hitachi Chemical Diagnostics, Inc. with the FDA for Hitachi S Test Reagent Cartridge Total Protein (tp) And Albumin (alb).
| Device ID | K131051 |
| 510k Number | K131051 |
| Device Name: | HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) |
| Classification | Turbidimetric, Total Protein |
| 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 | JGQ |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-15 |
| Decision Date | 2013-06-07 |
| Summary: | summary |