FDA 510(k) Application Details - K011389

Device Classification Name	Control, Hemoglobin, Abnormal   More FDA Info for this Device
510(K) Number	K011389
Device Name	Control, Hemoglobin, Abnormal
Applicant	CANTERBURY HEALTH LABORATORIES HAGLEY AVENUE CHRISTCHURCH, CANTERBURY NZ Other 510(k) Applications for this Company
Contact	MAURICE OWEN Other 510(k) Applications for this Contact
Regulation Number	864.7415   More FDA Info for this Regulation Number
Classification Product Code	JCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2001
Decision Date	06/21/2001
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