FDA 510(k) Application Details - K061413

Device Classification Name	Dna Probe, Nucleic Acid Amplification, Chlamydia   More FDA Info for this Device
510(K) Number	K061413
Device Name	Dna Probe, Nucleic Acid Amplification, Chlamydia
Applicant	GEN-PROBE, INC. 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121-4362 US Other 510(k) Applications for this Company
Contact	BRIAN J SHEA 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	05/22/2006
Decision Date	10/13/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review