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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, glycosylated hemoglobin
510(k) Number K021484
Device Name HEMOGLOBIN A1C CONTROL
Applicant
CANTERBURY SCIENTIFIC LTD.
21 WROXTON TERRACE
CHRISTCHURCH,  NZ
Applicant Contact MAURICE OWEN
Correspondent
CANTERBURY SCIENTIFIC LTD.
21 WROXTON TERRACE
CHRISTCHURCH,  NZ
Correspondent Contact MAURICE OWEN
Regulation Number864.7470
Classification Product Code
LCP  
Date Received05/08/2002
Decision Date 06/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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