TRU LEGIONELLA
Legionella, Spp., Elisa
MERIDIAN BIOSCIENCE, INC.
The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Tru Legionella.
Pre-market Notification Details
| Device ID | K113190 |
| 510k Number | K113190 |
| Device Name: | TRU LEGIONELLA |
| Classification | Legionella, Spp., Elisa |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Susan Bogar |
| Correspondent | Susan Bogar MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | MJH |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2012-02-24 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101267 | K113190 | 000 |
Trademark Results [TRU LEGIONELLA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRU LEGIONELLA 85551923 4255343 Live/Registered |
Meridian Bioscience, Inc. 2012-02-24 |
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