FDA 510(k) Application Details - K013819

Device Classification Name	System, Transport, Aerobic   More FDA Info for this Device
510(K) Number	K013819
Device Name	System, Transport, Aerobic
Applicant	SIERRA DIAGNOSTIC, L.L.C. 1800 MASSACHUSETTS AVE., NW SUITE 200 WASHINGTON, DC 20036-1221 US Other 510(k) Applications for this Company
Contact	DONALD R STONE Other 510(k) Applications for this Contact
Regulation Number	866.2900   More FDA Info for this Regulation Number
Classification Product Code	JTW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2001
Decision Date	02/28/2002
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