FDA 510(k) Application Details - K092705

Device Classification Name	Real Time Nucleic Acid Amplification System   More FDA Info for this Device
510(K) Number	K092705
Device Name	Real Time Nucleic Acid Amplification System
Applicant	ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 US Other 510(k) Applications for this Company
Contact	PAULA E MARTIN 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	09/03/2009
Decision Date	05/28/2010
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