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510(k) K872175

TDXR FLECAINIDE by Abbott Laboratories — Product Code LBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1987
Date Received
June 8, 1987
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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