FDA 510(k) Application Details - K053257

Device Classification Name	Device, Parasite Concentration   More FDA Info for this Device
510(K) Number	K053257
Device Name	Device, Parasite Concentration
Applicant	ALPHA-TEC SYSTEMS, INC. 12019 N.E. 99TH ST., #1780 VANCOUVER, WA 98682 US Other 510(k) Applications for this Company
Contact	RICHARD WILLIAMS Other 510(k) Applications for this Contact
Regulation Number	866.2900   More FDA Info for this Regulation Number
Classification Product Code	LKS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2005
Decision Date	05/12/2006
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