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510(k) K913867

URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) by Immunalysis Corporation — Product Code KLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1991
Date Received
August 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cocaine Metabolite
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

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