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510(k) K141320

LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls by Lin-Zhi International, Inc. — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2015
Date Received
May 20, 2014
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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