PREMIER PLATINUM HPSA
Helicobacter Pylori
MERIDIAN DIAGNOSTICS, INC.
The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Premier Platinum Hpsa.
Pre-market Notification Details
| Device ID | K980076 |
| 510k Number | K980076 |
| Device Name: | PREMIER PLATINUM HPSA |
| Classification | Helicobacter Pylori |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Allen D Nickol |
| Correspondent | Allen D Nickol MERIDIAN DIAGNOSTICS, 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 | 1998-01-08 |
| Decision Date | 1998-05-12 |
| Summary: | summary |
Trademark Results [PREMIER PLATINUM HPSA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PREMIER PLATINUM HPSA 75692761 2533289 Live/Registered |
MERIDIAN BIOSCIENCE, INC. 1999-04-28 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.