The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Premier Campy, Model 618096.
Device ID | K083464 |
510k Number | K083464 |
Device Name: | PREMIER CAMPY, MODEL 618096 |
Classification | Campylobacter Spp. |
Applicant | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
Contact | Susan D Rolih |
Correspondent | Susan D Rolih MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
Product Code | LQP |
CFR Regulation Number | 866.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-11-24 |
Decision Date | 2009-01-30 |
Summary: | summary |