The following data is part of a premarket notification filed by Trinity Biotech, Plc with the FDA for Captiam Syphilis-g Assay.
| Device ID | K014233 |
| 510k Number | K014233 |
| Device Name: | CAPTIAM SYPHILIS-G ASSAY |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY Co. Wicklow, IE |
| Contact | Fiona Campbell |
| Correspondent | Fiona Campbell TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY Co. Wicklow, IE |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-26 |
| Decision Date | 2002-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516744836 | K014233 | 000 |
| 05391516744829 | K014233 | 000 |
| 05391516746908 | K014233 | 000 |