FDA 510(k) Application Details - K011933

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K011933
Device Name	Assay, Glycosylated Hemoglobin
Applicant	PROVALIS DIAGNOSTICS LTD. 16809 BRIARDALE RD. ROCKVILLE, MD 20855 US Other 510(k) Applications for this Company
Contact	THOMAS M TSAKERIS 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	06/20/2001
Decision Date	11/02/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review