FDA 510(k) Application Details - K020229

Device Classification Name	Mixture, Hematology Quality Control   More FDA Info for this Device
510(K) Number	K020229
Device Name	Mixture, Hematology Quality Control
Applicant	R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. MINNEAPOLIS, MN 55413 US Other 510(k) Applications for this Company
Contact	RALPH E HOGANCAMP Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	JPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/23/2002
Decision Date	02/06/2002
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