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510(k) K081231

ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 by Abbott Laboratories — Product Code DLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2008
Date Received
May 1, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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