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510(k) K871549

RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] by Immunalysis Corporation — Product Code KLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1987
Date Received
April 14, 1987
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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  • K904995 — ABUSCREEN ONLINE TM FOR COCAINE METABOLITE (November 28, 1990)
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