FDA 510(k) Application Details - K023032

Device Classification Name	Standards And Controls, Hemoglobin, Normal And Abnormal   More FDA Info for this Device
510(K) Number	K023032
Device Name	Standards And Controls, Hemoglobin, Normal And Abnormal
Applicant	BIORESOURCE TECHNOLOGY, INC. 1531 N.W. 65TH AVE. FORT LAUDERDALE, FL 33313-4542 US Other 510(k) Applications for this Company
Contact	ALAN POSNER Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	GFS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2002
Decision Date	10/08/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review