Medical Device Manufacturer · US , Jamestown , NY

Trinity Biotech, Plc

5 submissions · 5 cleared · Since 1999
5
Total
5
Cleared
0
Denied

Trinity Biotech, Plc — FDA 510(k) Submissions

Trinity Biotech, Plc has submitted 5 FDA 510(k) premarket notifications since 1999, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Linked Immunoabsorption Assay, Treponema Pallidum, Antisera, All Groups, Streptococcus Spp., Antigens, All Groups, Streptococcus Spp., Helicobacter Pylori . Use the specialty filter in the sidebar to narrow results.

5 devices
1–5 of 5
CAPTIAM SYPHILIS-G ASSAY
K014233 · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · Microbiology
Jan 2002 29d
UNI-GOLD STREP A TEST KIT
K011709 · GTZ Antisera, All Groups, Streptococcus Spp. · Microbiology
Nov 2001 157d
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
K001525 · LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · Microbiology
Nov 2000 197d
UNI-GOLD H. PYLORI
K991697 · LYR Helicobacter Pylori · Microbiology
Dec 1999 217d
UNI-GOLD STREP A TEST KIT
K982373 · GTY Antigens, All Groups, Streptococcus Spp. · Microbiology
Feb 1999 219d
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