FDA 510(k) Application Details - K191442

Device Classification Name	Campylobacter Spp.   More FDA Info for this Device
510(K) Number	K191442
Device Name	Campylobacter Spp.
Applicant	Techlab, Inc. 2001 Kraft Drive Blacksburg, VA 24085 US Other 510(k) Applications for this Company
Contact	Donna Link Other 510(k) Applications for this Contact
Regulation Number	866.3110   More FDA Info for this Regulation Number
Classification Product Code	LQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2019
Decision Date	06/20/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review