The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Premier Platinum Hpsa Plus, Models 601396, 601480.
| Device ID | K053335 |
| 510k Number | K053335 |
| Device Name: | PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 |
| 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 | 2005-12-01 |
| Decision Date | 2006-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885380163576 | K053335 | 000 |