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510(k) K854044

TDX BARBITURATES by Abbott Laboratories — Product Code LGQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1985
Date Received
October 2, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
Submission Type

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