FDA 510(k) Application Details - K040077

Device Classification Name	Apparatus, Automated Blood Cell Diluting   More FDA Info for this Device
510(K) Number	K040077
Device Name	Apparatus, Automated Blood Cell Diluting
Applicant	IMMUNICON CORP. 3401 MASONS MILL RD. HUNTINGDON VALLEY, PA 19006-3574 US Other 510(k) Applications for this Company
Contact	PETER J SCOTT Other 510(k) Applications for this Contact
Regulation Number	864.5240   More FDA Info for this Regulation Number
Classification Product Code	GKH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/14/2004
Decision Date	03/12/2004
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