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510(k) K133710

LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS by Lin-Zhi International, Inc. — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2014
Date Received
December 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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