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510(k) K862554

IMMPULSE PHENYTOIN ASSAY REAGENT by Sclavo, Inc. — Product Code LGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1986
Date Received
July 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

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