FDA 510(k) Application Details - K090191

Device Classification Name	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test   More FDA Info for this Device
510(K) Number	K090191
Device Name	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Applicant	HANDYLAB, INC 5230 S STATE ROAD ANN ARBOR, MI 48108 US Other 510(k) Applications for this Company
Contact	MARTHA J RUMFORD 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	01/27/2009
Decision Date	05/27/2010
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