FDA 510(k) Application Details - K140447

Device Classification Name	Real Time Nucleic Acid Amplification System   More FDA Info for this Device
510(K) Number	K140447
Device Name	Real Time Nucleic Acid Amplification System
Applicant	Becton, Dickinson and Company 7 LOVETON CIRCLE SPARKS, MD 21152 US Other 510(k) Applications for this Company
Contact	SHERMA WINSTON Other 510(k) Applications for this Contact
Regulation Number	862.2570   More FDA Info for this Regulation Number
Classification Product Code	OOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2014
Decision Date	05/20/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review