The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Immunocard H. Pylori.
| Device ID | K941560 |
| 510k Number | K941560 |
| Device Name: | IMMUNOCARD H. PYLORI |
| Classification | Helicobacter Pylori |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Allen D Nickol |
| Correspondent | Allen D Nickol MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-01 |
| Decision Date | 1994-12-08 |