FDA 510(k) Application Details - K962864

Device Classification Name	Calibrator For Hemoglobin And Hematocrit Measurement   More FDA Info for this Device
510(K) Number	K962864
Device Name	Calibrator For Hemoglobin And Hematocrit Measurement
Applicant	ALKO DIAGNOSTIC CORP. 333 FISKE ST. HOLLISTON, MA 01746 US Other 510(k) Applications for this Company
Contact	JANET A MCGRATH 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	07/23/1996
Decision Date	12/18/1996
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