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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Hemoglobin, Abnormal
510(k) Number K011389
Device Name HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
Applicant
Canterbury Health Laboratories
Hagley Ave.
Christchurch, Canterbury,  NZ
Applicant Contact MAURICE OWEN
Correspondent
Canterbury Health Laboratories
Hagley Ave.
Christchurch, Canterbury,  NZ
Correspondent Contact MAURICE OWEN
Regulation Number864.7415
Classification Product Code
JCM  
Date Received05/07/2001
Decision Date 06/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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