FDA 510(k) Application Details - K041130

Device Classification Name	Calibrator For Hemoglobin And Hematocrit Measurement   More FDA Info for this Device
510(K) Number	K041130
Device Name	Calibrator For Hemoglobin And Hematocrit Measurement
Applicant	CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1660 N.W. 65TH AVE., SUITE 2 PLANTATION, FL 33313 US Other 510(k) Applications for this Company
Contact	ANDREW SWANSON Other 510(k) Applications for this Contact
Regulation Number	864.8165   More FDA Info for this Regulation Number
Classification Product Code	KRZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2004
Decision Date	06/10/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review