FDA 510(k) Application Details - K143312

Device Classification Name	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test   More FDA Info for this Device
510(K) Number	K143312
Device Name	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Applicant	GREAT BASIN CORPORATION 2441 SOUTH 3850 WEST Salt Lake City, UT 84120 US Other 510(k) Applications for this Company
Contact	Chuck Owen Other 510(k) Applications for this Contact
Regulation Number	866.3740   More FDA Info for this Regulation Number
Classification Product Code	NJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2014
Decision Date	04/21/2015
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