FDA 510(k) Application Details - K003991

Device Classification Name	Calibrator For Cell Indices   More FDA Info for this Device
510(K) Number	K003991
Device Name	Calibrator For Cell Indices
Applicant	R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. MINNEAPOLIS, MN 55413 US Other 510(k) Applications for this Company
Contact	KENNETH T EDDS Other 510(k) Applications for this Contact
Regulation Number	864.8150   More FDA Info for this Regulation Number
Classification Product Code	KRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2000
Decision Date	01/16/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review