The following data is part of a premarket notification filed by Meridian Bioscience, Inc with the FDA for Immunocard Stat! Hpsa.
| Device ID | K153661 |
| 510k Number | K153661 |
| Device Name: | ImmunoCard STAT! HpSA |
| Classification | Helicobacter Pylori |
| Applicant | Meridian Bioscience, Inc 3471 River Hills Drive Cincinnati, OH 45244 |
| Contact | Susan Rolih |
| Correspondent | Susan Rolih Meridian Bioscience, Inc 3471 River Hills Drive 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 | 2015-12-21 |
| Decision Date | 2016-03-14 |