The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Curian Hpsa, Curian Analyzer.
| Device ID | K192817 |
| 510k Number | K192817 |
| Device Name: | Curian HpSA, Curian Analyzer |
| Classification | Helicobacter Pylori |
| Applicant | Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244 |
| Contact | Cathlena Martinez |
| Correspondent | Cathlena Martinez 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 | 2019-10-01 |
| Decision Date | 2020-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733102271 | K192817 | 000 |
| 00840733101427 | K192817 | 000 |