Trinity Biotech
Trinity Biotech appears in FDA public data with 0 recalls, 12 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on October 23, 2017.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K172254 | Lyme B. burgdorferi (IgM) MarStripe Test | October 23, 2017 |
| K163095 | Lyme B. burgdorferi (IgG) MarStripe Test | February 1, 2017 |
| K120001 | UNIGOLD GIARDIA | March 1, 2013 |
| K121565 | UNI-GOLD CRYPTOSPORIDIUM | February 8, 2013 |
| K083896 | DESTINY MAX COAGULATION ANALYZER | July 2, 2009 |
| K033059 | HERPES GROUP IGG | November 26, 2003 |
| K014233 | CAPTIAM SYPHILIS-G ASSAY | January 24, 2002 |
| K011709 | UNI-GOLD STREP A TEST KIT | November 8, 2001 |
| K001525 | CAPTIA SYPHILIS-G ELISA TEST SYSTEM | November 29, 2000 |
| K991697 | UNI-GOLD H. PYLORI | December 21, 1999 |
| K982373 | UNI-GOLD STREP A TEST KIT | February 11, 1999 |
| K964424 | ROTAVIRUS EIA | August 8, 1997 |