FDA 510(k) Application Details - K042750

Device Classification Name	Material, Quality Control, Semen Analysis   More FDA Info for this Device
510(K) Number	K042750
Device Name	Material, Quality Control, Semen Analysis
Applicant	BIOSCREEN INC. 889 BROADWAY - SUITE 6A NEW YORK, NY 10003 US Other 510(k) Applications for this Company
Contact	ALICE DEUTSCH Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	NRF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/04/2004
Decision Date	10/29/2004
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