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 |