FDA 510(k) Application Details - K151690

Device Classification Name	Real Time Nucleic Acid Amplification System   More FDA Info for this Device
510(K) Number	K151690
Device Name	Real Time Nucleic Acid Amplification System
Applicant	ALERE SCARBOROUGH, INC. 10 Southgate Road Scarborough, ME 04074 US Other 510(k) Applications for this Company
Contact	Angela Drysdale 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	06/23/2015
Decision Date	07/16/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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