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510(k) K123271

ABBOTT PHENOBARBITAL ASSAY by Microgenics Corp. — Product Code DLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2013
Date Received
October 19, 2012
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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