The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Alpha.
| Device ID | K910222 |
| 510k Number | K910222 |
| Device Name: | COBAS ALPHA |
| Classification | Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair, NJ 07042 |
| Contact | Alex Wesolowski |
| Correspondent | Alex Wesolowski ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair, NJ 07042 |
| Product Code | JJG |
| CFR Regulation Number | 862.2140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-18 |
| Decision Date | 1991-02-27 |