FDA 510(k) Application Details - K172254

Device Classification Name	Reagent, Borrelia Serological Reagent   More FDA Info for this Device
510(K) Number	K172254
Device Name	Reagent, Borrelia Serological Reagent
Applicant	Trinity Biotech 60 Pineview Dr. Buffalo, NY 14031 US Other 510(k) Applications for this Company
Contact	Kevin Lawson Other 510(k) Applications for this Contact
Regulation Number	866.3830   More FDA Info for this Regulation Number
Classification Product Code	LSR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2017
Decision Date	10/23/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review