Trinity Biotech, Plc: FDA clearances and approvals
Trinity Biotech, Plc has 5 FDA 510(k) clearances (first 1999, latest 2002), across 4 product codes in 1 review panel. Median 510(k) review time: 197 days. It files with the SEC as TRINITY BIOTECH PLC (TRIB).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | 2 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 1 |
| LYR | Helicobacter Pylori | 1 | 1 |
Review panels
- Microbiology (5)
Most recent Trinity Biotech, Plc 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K014233 | CAPTIAM SYPHILIS-G ASSAY | LIP | 2002-01-24 | 29 |
| K011709 | UNI-GOLD STREP A TEST KIT | GTZ | 2001-11-08 | 157 |
| K001525 | CAPTIA SYPHILIS-G ELISA TEST SYSTEM | LIP | 2000-11-29 | 197 |
| K991697 | UNI-GOLD H. PYLORI | LYR | 1999-12-21 | 217 |
| K982373 | UNI-GOLD STREP A TEST KIT | GTY | 1999-02-11 | 219 |
Recalls
openFDA lists no recalls under a recalling firm named Trinity Biotech, Plc.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
SEC filings
TRINITY BIOTECH PLC (TRIB): EDGAR filings, CIK 888721. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Trinity Biotech, Plc have?
Trinity Biotech, Plc has 5 FDA 510(k) clearances (first 1999, latest 2002), across 4 product codes in 1 review panel.
How long does FDA take to clear Trinity Biotech, Plc's 510(k)s?
The median time from FDA receipt to decision across Trinity Biotech, Plc's cleared 510(k)s is 197 days.
What devices does Trinity Biotech, Plc make?
Its most frequent FDA product codes are LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum, 2); GTY (Antigens, All Groups, Streptococcus Spp., 1); GTZ (Antisera, All Groups, Streptococcus Spp., 1).
Has Trinity Biotech, Plc had device recalls?
openFDA lists no recalls under a recalling firm name matching Trinity Biotech, Plc. Related entities may recall under other names.
Next steps
- See all 5 Trinity Biotech, Plc clearances with predicates and recalls
- Run predicate analysis for product code LIP, Trinity Biotech, Plc's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.