Medical Device Manufacturer · US , Jamestown , NY

Trinity Biotech - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2009
5
Total
5
Cleared
0
Denied

FDA 510(k) Regulatory Record - Trinity Biotech Microbiology ✕

4 devices
1-4 of 4
Cleared Oct 23, 2017
Lyme B. burgdorferi (IgM) MarStripe Test
K172254 · LSR
Microbiology · 89d
Cleared Feb 01, 2017
Lyme B. burgdorferi (IgG) MarStripe Test
K163095 · LSR
Microbiology · 89d
Cleared Mar 01, 2013
UNIGOLD GIARDIA
K120001 · MHI
Microbiology · 423d
Cleared Feb 08, 2013
UNI-GOLD CRYPTOSPORIDIUM
K121565 · MHJ
Microbiology · 255d
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