COBAS MIRA
Analyzer, Chemistry, Micro, For Clinical Use
ROCHE DIAGNOSTIC SYSTEMS, INC.
The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas Mira.
Pre-market Notification Details
| Device ID | K851172 |
| 510k Number | K851172 |
| Device Name: | COBAS MIRA |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley, NJ 07110 |
| Contact | Griffin Fitzgerald |
| Correspondent | Griffin Fitzgerald ROCHE DIAGNOSTIC SYSTEMS, INC. DIV. OF HOFFMANN-LA ROCHE, INC Nutley, NJ 07110 |
| Product Code | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-22 |
| Decision Date | 1985-05-02 |
Trademark Results [COBAS MIRA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COBAS MIRA 73805685 1579910 Dead/Cancelled |
ROCHE DIAGNOSTIC SYSTEMS, INC. 1989-06-08 |
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