The following data is part of a premarket notification filed by Trinity Biotech, Plc with the FDA for Uni-gold Strep A Test Kit.
| Device ID | K982373 |
| 510k Number | K982373 |
| Device Name: | UNI-GOLD STREP A TEST KIT |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| 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 | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-07 |
| Decision Date | 1999-02-11 |
| Summary: | summary |