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510(k) K050988

OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS by Lin-Zhi International, Inc. — Product Code DLG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2006
Date Received
April 19, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Liquid, Glc
Device Class
Class I
Regulation Number
862.2250
Review Panel
TX
Submission Type

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