FDA 510(k) Application Details - K011679

Device Classification Name	More FDA Info for this Device
510(K) Number	K011679
Device Name	FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
Applicant	EMBRYOTECH LABORATORIES, INC. 19 SEDGEMEADOW RD. WAYLAND, MA 01778 US Other 510(k) Applications for this Company
Contact	ANN D MCGONIGLE 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	05/30/2001
Decision Date	08/15/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review