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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
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Contact
MAURICE OWEN
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Regulation Number
864.7415
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Classification Product Code
JCM
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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
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