The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Tru Rsv.
| Device ID | K071101 | 
| 510k Number | K071101 | 
| Device Name: | TRU RSV | 
| Classification | Antisera, Cf, Poliovirus 1-3 | 
| 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 | GOG | 
| CFR Regulation Number | 866.3405 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2007-04-19 | 
| Decision Date | 2007-10-18 | 
| Summary: | summary | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 00840733101847 | K071101 | 000 | 
| 00840733101977 | K071101 | 000 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  TRU RSV  78901518  3407186 Live/Registered | Meridian Bioscience, Inc. 2006-06-06 |