FDA 510(k) Application Details - K960894

Device Classification Name	Control, White-Cell   More FDA Info for this Device
510(K) Number	K960894
Device Name	Control, White-Cell
Applicant	STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 OMAHA, NE 68144 US Other 510(k) Applications for this Company
Contact	THEODORE W HEISE Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	GGL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/1996
Decision Date	05/24/1996
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