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510(k) K051088

MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS by Lin-Zhi International, Inc. — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2005
Date Received
April 28, 2005
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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