Medical Device Manufacturer · US , Jamestown , NY

Trinity Biotech, Plc - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1999

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Trinity Biotech, Plc Microbiology ✕

5 devices

1-5 of 5

Cleared Jan 24, 2002

CAPTIAM SYPHILIS-G ASSAY

Microbiology · 29d

Cleared Nov 08, 2001

UNI-GOLD STREP A TEST KIT

Microbiology · 157d

Cleared Nov 29, 2000

CAPTIA SYPHILIS-G ELISA TEST SYSTEM

Microbiology · 197d

Cleared Dec 21, 1999

UNI-GOLD H. PYLORI

Microbiology · 217d

Cleared Feb 11, 1999

UNI-GOLD STREP A TEST KIT

Microbiology · 219d