FDA 510(k) Application Details - K110923

Device Classification Name	Dna Probe, Nucleic Acid Amplification, Chlamydia   More FDA Info for this Device
510(K) Number	K110923
Device Name	Dna Probe, Nucleic Acid Amplification, Chlamydia
Applicant	ROCHE MOLECULAR SYSTEMS, INC. 4300 HACIENDA DRIVE PLEASANTON, CA 94588-2722 US Other 510(k) Applications for this Company
Contact	JAMES BONDS Other 510(k) Applications for this Contact
Regulation Number	866.3120   More FDA Info for this Regulation Number
Classification Product Code	MKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2011
Decision Date	01/24/2012
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