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Trinity Biotech

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K172254 Lyme B. burgdorferi (IgM) MarStripe TestLSR2017-10-23 View
510(k) K163095 Lyme B. burgdorferi (IgG) MarStripe TestLSR2017-02-01 View
510(k) K120001 UNIGOLD GIARDIAMHI2013-03-01 View
510(k) K121565 UNI-GOLD CRYPTOSPORIDIUMMHJ2013-02-08 View
510(k) K083896 DESTINY MAX COAGULATION ANALYZERJPA2009-07-02 View
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