The following data is part of a premarket notification filed by Trinity Biotech Usa with the FDA for Ena Profile Elisa Test System.
| Device ID | K993839 |
| 510k Number | K993839 |
| Device Name: | ENA PROFILE ELISA TEST SYSTEM |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | TRINITY BIOTECH USA 2823 GIRTS RD. Jamestown, NY 14702 |
| Contact | Wayne Kvetkosky |
| Correspondent | Wayne Kvetkosky TRINITY BIOTECH USA 2823 GIRTS RD. Jamestown, NY 14702 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-12 |
| Decision Date | 2000-01-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516743822 | K993839 | 000 |