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510(k) K853113

TD TRICYCLIC ANTIDEPRESSANTS by Abbott Laboratories — Product Code LFG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1985
Date Received
July 24, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Tricyclic Antidepressant Drugs
Device Class
Class II
Regulation Number
862.3910
Review Panel
TX
Submission Type

Intended to measure any of the tricyclic antidepressant drugs in serum or urine.

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