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510(k) K033334

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2003
Date Received
October 16, 2003
Clearance Type
Special
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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