FDA 510(k) Application Details - K063864

Device Classification Name	More FDA Info for this Device
510(K) Number	K063864
Device Name	QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS
Applicant	MEDICAL ELECTRONIC SYSTEMS LTD. 575 SHIRLYNN CT. LOS ALTOS, CA 94022 US Other 510(k) Applications for this Company
Contact	Erika B Ammirati Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2006
Decision Date	03/26/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review