The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Premier Platinum Hpsa Plus.
| Device ID | K182559 |
| 510k Number | K182559 |
| Device Name: | PREMIER Platinum HpSA PLUS |
| Classification | Helicobacter Pylori |
| Applicant | Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244 |
| Contact | Jack Rogers |
| Correspondent | Jack Rogers 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 | 2018-09-17 |
| Decision Date | 2018-11-05 |
| Summary: | summary |