FDA 510(k) Application Details - K942525

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K942525
Device Name	Counter, Differential Cell
Applicant	CEA AMERICA CORP. 5300 MEMORIAL DR. #310 HOUSTON, TX 77007 US Other 510(k) Applications for this Company
Contact	THOMAS BURTNETT Other 510(k) Applications for this Contact
Regulation Number	864.5220   More FDA Info for this Regulation Number
Classification Product Code	GKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/1994
Decision Date	06/05/1996
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