The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Immunocardstat Hpsa.
| Device ID | K032222 |
| 510k Number | K032222 |
| Device Name: | IMMUNOCARDSTAT HPSA |
| Classification | Helicobacter Pylori |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Susan Rolih |
| Correspondent | Susan Rolih MERIDIAN BIOSCIENCE, 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 | 2003-07-21 |
| Decision Date | 2003-12-05 |
| Summary: | summary |