The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Meritec(tm)-campy (jcl).
| Device ID | K880389 |
| 510k Number | K880389 |
| Device Name: | MERITEC(TM)-CAMPY (JCL) |
| Classification | Campylobacter Spp. |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Clinton, Phd |
| Correspondent | Clinton, Phd MERIDIAN DIAGNOSTICS, 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 | 1988-01-28 |
| Decision Date | 1988-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813545026288 | K880389 | 000 |