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510(k) K944932

PHENOBARBITAL FLEX REAGENT CARTRIDGE by Dupont Medical Products — Product Code DLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1994
Date Received
October 6, 1994
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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