FDA 510(k) Application Details - K020689

Device Classification Name	System, Mycolic Acid Analysis, Mycobacterium Tuberculosis   More FDA Info for this Device
510(K) Number	K020689
Device Name	System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
Applicant	MIDI, INC. 125 SANDY DR. NEWARK, DE 19713-1148 US Other 510(k) Applications for this Company
Contact	WILLIAMS STIMSON Other 510(k) Applications for this Contact
Regulation Number	866.3370   More FDA Info for this Regulation Number
Classification Product Code	NJO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2002
Decision Date	10/31/2002
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