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 |