The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Reagent For C02.
| Device ID | K911838 |
| 510k Number | K911838 |
| Device Name: | ROCHE REAGENT FOR C02 |
| Classification | Coulometric Method, Carbon-dioxide |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair, NJ 07042 |
| Contact | Carol L Krieger |
| Correspondent | Carol L Krieger ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair, NJ 07042 |
| Product Code | CHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-25 |
| Decision Date | 1991-07-19 |