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510(k) K913737

IL TEST(TM) COCAINE by Instrumentation Laboratory CO — Product Code JXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1991
Date Received
August 20, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cocaine
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

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