FDA 510(k) Application Details - K971919

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K971919
Device Name	Assay, Glycosylated Hemoglobin
Applicant	FLEXSITE DIAGNOSTICS, INC. 1900 K STREET, N.W. WASHINGTON, DC 20006-1108 US Other 510(k) Applications for this Company
Contact	DONALD R STONE Other 510(k) Applications for this Contact
Regulation Number	864.7470   More FDA Info for this Regulation Number
Classification Product Code	LCP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/1997
Decision Date	09/05/1997
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