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510(k) K020769

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2002
Date Received
March 7, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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