FDA 510(k) Application Details - K050352

Device Classification Name	Discs, Strips And Reagents, Microorganism Differentiation   More FDA Info for this Device
510(K) Number	K050352
Device Name	Discs, Strips And Reagents, Microorganism Differentiation
Applicant	AMERITEK RESEARCH LLC 15205 3RD DR. SE MILL CREEK, WA 98012 US Other 510(k) Applications for this Company
Contact	KUD CHAIANG YEE Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	JTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2005
Decision Date	09/01/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review