FDA 510(k) Application Details - K162772

Device Classification Name	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test   More FDA Info for this Device
510(K) Number	K162772
Device Name	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Applicant	LUMINEX CORPORATION 12212 TECHNOLOGY BLVD. AUSTIN, TX 78727 US Other 510(k) Applications for this Company
Contact	CHRISTIE HUGHES 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	10/03/2016
Decision Date	12/23/2016
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