The following data is part of a premarket notification filed by Hitachi Chemical Diagnostics, Inc. with the FDA for S Test Reagent Cartridge Carbon Dioxide (co2).
| Device ID | K140248 |
| 510k Number | K140248 |
| Device Name: | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) |
| Classification | Enzymatic, Carbon-dioxide |
| 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 | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-30 |
| Decision Date | 2014-03-11 |
| Summary: | summary |