FDA 510(k) Application Details - K170284

Device Classification Name	More FDA Info for this Device
510(K) Number	K170284
Device Name	Great Basin Bordetella Direct Test
Applicant	GREAT BASIN SCIENTIFIC, INC. 2441 S. 3850 WEST SUITE 100 SALT LAKE CITY, UT 84120 US Other 510(k) Applications for this Company
Contact	SUZETTE CHANCE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/2017
Decision Date	03/31/2017
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