The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Curian Campy.
| Device ID | K210976 |
| 510k Number | K210976 |
| Device Name: | Curian Campy |
| Classification | Campylobacter Spp. |
| Applicant | Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244 |
| Contact | Heather Planck |
| Correspondent | Heather Planck Meridian Bioscience, Inc. 3471 River Hills Drive 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 | 2021-04-01 |
| Decision Date | 2021-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733102387 | K210976 | 000 |