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510(k) K941615

AXSYM VALPROIC ACID by Abbott Laboratories — Product Code LEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1994
Date Received
April 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Valproic Acid
Device Class
Class II
Regulation Number
862.3645
Review Panel
TX
Submission Type

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