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510(k) K970396

HUMAN CHORIONIC GONADOTROPIN CALIBRATOR by Dade Chemistry Systems, Inc. — Product Code JIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1997
Date Received
February 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Surrogate
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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