FDA 510(k) Application Details - K080739

Device Classification Name	Dna Probe, Nucleic Acid Amplification, Chlamydia   More FDA Info for this Device
510(K) Number	K080739
Device Name	Dna Probe, Nucleic Acid Amplification, Chlamydia
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	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	03/17/2008
Decision Date	07/10/2008
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