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510(k) K903993

MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT by Immunotech Corp. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1990
Date Received
August 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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