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 |