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510(k) K002331

PROFILE-ER by Medtox Diagnostics, Inc. — Product Code DIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2001
Date Received
August 1, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

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