FDA 510(k) Applications Submitted by TRINITY BIOTECH

FDA 510(k) Number Submission Date Device Name Applicant
K083896 12/29/2008 DESTINY MAX COAGULATION ANALYZER TRINITY BIOTECH
K172254 07/26/2017 Lyme B. burgdorferi (IgM) MarStripe Test Trinity Biotech
K163095 11/04/2016 Lyme B. burgdorferi (IgG) MarStripe Test Trinity Biotech
K120001 01/03/2012 UNIGOLD GIARDIA TRINITY BIOTECH
K121565 05/29/2012 UNI-GOLD CRYPTOSPORIDIUM TRINITY BIOTECH


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