The following data is part of a premarket notification filed by Trinity Biotech, Plc with the FDA for Captia Syphilis-g Elisa Test System.
| Device ID | K001525 |
| 510k Number | K001525 |
| Device Name: | CAPTIA SYPHILIS-G ELISA TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | TRINITY BIOTECH, PLC PO BOX 1059, 2823 GIRTS RD. Jamestown, NY 14702 -1059 |
| Contact | Wayne Kvetkosky |
| Correspondent | Wayne Kvetkosky TRINITY BIOTECH, PLC PO BOX 1059, 2823 GIRTS RD. Jamestown, NY 14702 -1059 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-16 |
| Decision Date | 2000-11-29 |