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510(k) K151203

Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set by Immunalysis Corporation — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2015
Date Received
May 5, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

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