The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Cobas Mira Plus.
| Device ID | K920402 |
| 510k Number | K920402 |
| Device Name: | ROCHE COBAS MIRA PLUS |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| 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 | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-31 |
| Decision Date | 1992-04-29 |