FDA 510(k) Application Details - K021484

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K021484
Device Name	Assay, Glycosylated Hemoglobin
Applicant	CANTERBURY SCIENTIFIC LTD. 21 WROXTON TERRACE CHRISTCHURCH NZ Other 510(k) Applications for this Company
Contact	MAURICE OWEN 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	05/08/2002
Decision Date	06/14/2002
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