TRU FLU
Devices Detecting Influenza A, B, And C Virus Antigens
MERIDIAN BIOSCIENCE, INC.
The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Tru Flu.
Pre-market Notification Details
| Device ID | K071657 |
| 510k Number | K071657 |
| Device Name: | TRU FLU |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Susan Rolih |
| Correspondent | Susan Rolih MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-18 |
| Decision Date | 2007-11-15 |
| Summary: | summary |
Trademark Results [TRU FLU]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRU FLU 78901495 3407185 Dead/Cancelled |
Meridian Bioscience, Inc. 2006-06-06 |
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