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510(k) K840596

QUINIDINE ANALYTICAL TEST PACK by E.I. Dupont DE Nemours & Co., Inc. — Product Code LBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1984
Date Received
February 9, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Quinidine
Device Class
Class II
Regulation Number
862.3320
Review Panel
TX
Submission Type

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