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510(k) K891093

ACA (R) DIGITOXIN CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc. — Product Code DCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1989
Date Received
March 2, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Beta-Globulin, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5160
Review Panel
IM
Submission Type

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