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510(k) K040570

RANDOX METHADONE ASSAY by Randox Laboratories, Ltd. — Product Code DJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2004
Date Received
March 4, 2004
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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