Lyme B. Burgdorferi (IgG) MarStripe Test

Reagent, Borrelia Serological Reagent

Trinity Biotech

The following data is part of a premarket notification filed by Trinity Biotech with the FDA for Lyme B. Burgdorferi (igg) Marstripe Test.

Pre-market Notification Details

Device IDK163095
510k NumberK163095
Device Name:Lyme B. Burgdorferi (IgG) MarStripe Test
ClassificationReagent, Borrelia Serological Reagent
Applicant Trinity Biotech 60 Pineview Dr. Buffalo,  NY  14031
ContactKevin Lawson
CorrespondentKevin Lawson
Trinity Biotech 60 Pineview Dr. Buffalo,  NY  14031
Product CodeLSR  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-04
Decision Date2017-02-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845714004728 K163095 000
00845714004711 K163095 000
00845714004704 K163095 000

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