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510(k) K023252

RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 by Icn Biomedicals, Inc. — Product Code DJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2002
Date Received
September 30, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Methadone
Device Class
Class II
Regulation Number
862.3620
Review Panel
TX
Submission Type

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