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510(k) K813597

TDX PRIMIDONE by Abbott Laboratories — Product Code DJD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1982
Date Received
December 28, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Primidone
Device Class
Class II
Regulation Number
862.3680
Review Panel
TX
Submission Type

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