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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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