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510(k) K780495

DIGITOXIN by Diagnostic Products Corp. — Product Code DJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1978
Date Received
March 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Digitoxin Control Serum, Ria
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

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