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Trinity Biotech

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K172254Lyme B. burgdorferi (IgM) MarStripe TestOctober 23, 2017
K163095Lyme B. burgdorferi (IgG) MarStripe TestFebruary 1, 2017
K120001UNIGOLD GIARDIAMarch 1, 2013
K121565UNI-GOLD CRYPTOSPORIDIUMFebruary 8, 2013
K083896DESTINY MAX COAGULATION ANALYZERJuly 2, 2009
K033059HERPES GROUP IGGNovember 26, 2003
K014233CAPTIAM SYPHILIS-G ASSAYJanuary 24, 2002
K011709UNI-GOLD STREP A TEST KITNovember 8, 2001
K001525CAPTIA SYPHILIS-G ELISA TEST SYSTEMNovember 29, 2000
K991697UNI-GOLD H. PYLORIDecember 21, 1999
K982373UNI-GOLD STREP A TEST KITFebruary 11, 1999
K964424ROTAVIRUS EIAAugust 8, 1997