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510(k) K863888

DU PONT PHENYTOIN ASSAY AND CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc. — Product Code DIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1986
Date Received
October 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Free Radical Assay, Cocaine
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

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