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510(k) K011389

HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) by Canterbury Health Laboratories — Product Code JCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2001
Date Received
May 7, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hemoglobin, Abnormal
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

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