FDA 510(k) Application Details - K120138

Device Classification Name	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen   More FDA Info for this Device
510(K) Number	K120138
Device Name	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Applicant	BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC) 7 LOVETON CIRCLE, MAIL CODE 614 SPARKS, MD 21152 US Other 510(k) Applications for this Company
Contact	RAYMOND J BOULE Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	NQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/17/2012
Decision Date	07/05/2012
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