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510(k) K080455

RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 by Quantrx Biomedical Corporation — Product Code LAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2008
Date Received
February 20, 2008
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

Other clearances by Quantrx Biomedical Corporation

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  • K070484 — QUANTRX FEMALE FERTILITY TEST (October 22, 2007)

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