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510(k) K051577

IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS by Immunalysis Corporation — Product Code LAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2005
Date Received
June 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

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