Trinity Biotech, Plc: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Trinity Biotech, Plc” (first 1999, latest 2002), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 197 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
TRINITY BIOTECH PLC (TRIB): EDGAR filings, CIK 888721. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Trinity Laboratories, Inc. (44 510(k)s)
- Trinity Biotech USA (11 510(k)s)
- Trinity Biotech (7 510(k)s)
- Trinity Orthopedics, LLC (2 510(k)s)
- Trinity Biotech (Primus Corporation, Dba Trinity Biotech) (1 510(k)s)
- Trinity Guardion (1 510(k)s)
- Trinity Medical Solutions (1 510(k)s)
- Trinity Partners, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Trinity Biotech, Plc?
FDA lists 5 510(k) clearances under the applicant name “Trinity Biotech, Plc” (first 1999, latest 2002), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Trinity Biotech, Plc?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trinity Biotech, Plc is 197 days.
Which FDA product codes appear under Trinity Biotech, Plc?
The most frequent FDA product codes under this applicant name are LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum, 2); GTY (Antigens, All Groups, Streptococcus Spp., 1); GTZ (Antisera, All Groups, Streptococcus Spp., 1).
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. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.