OPERA SYSTEM
Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use
MILES, INC.
The following data is part of a premarket notification filed by Miles, Inc. with the FDA for Opera System.
Pre-market Notification Details
| Device ID | K943376 |
| 510k Number | K943376 |
| Device Name: | OPERA SYSTEM |
| Classification | Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use |
| Applicant | MILES, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca, Jr. |
| Correspondent | Gabriel J Muraca, Jr. MILES, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JJC |
| CFR Regulation Number | 862.2150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-13 |
| Decision Date | 1994-09-14 |
Trademark Results [OPERA SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPERA SYSTEM 75382684 not registered Dead/Abandoned |
FemRx, Inc. 1997-10-30 |
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