FDA 510(k) Application Details - K191398

Device Classification Name	Reagent, Borrelia Serological Reagent   More FDA Info for this Device
510(K) Number	K191398
Device Name	Reagent, Borrelia Serological Reagent
Applicant	ZEUS Scientific Inc. P.O. BOX 38 Raritan, NJ 08869 US Other 510(k) Applications for this Company
Contact	Mark J. Kopnitsky 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	05/24/2019
Decision Date	07/29/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review