FDA 510(k) Application Details - K163095

Device Classification Name	Reagent, Borrelia Serological Reagent   More FDA Info for this Device
510(K) Number	K163095
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	11/04/2016
Decision Date	02/01/2017
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