The following data is part of a premarket notification filed by Trinity Biotech, Plc with the FDA for Uni-gold H. Pylori.
| Device ID | K991697 |
| 510k Number | K991697 |
| Device Name: | UNI-GOLD H. PYLORI |
| Classification | Helicobacter Pylori |
| Applicant | TRINITY BIOTECH, PLC 575 Shirlynn Court Los Altos, CA 94022 |
| Contact | Erika B Ammirati |
| Correspondent | Erika B Ammirati TRINITY BIOTECH, PLC 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-18 |
| Decision Date | 1999-12-21 |
| Summary: | summary |