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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Chromatography, Methamphetamine
510(k) Number K010496
Device Name CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
Applicant
MICROGENICS CORP.
46360 FREMONT BLVD.
FREMONT,  CA  94538
Applicant Contact SHERRIE RINNE
Correspondent
MICROGENICS CORP.
46360 FREMONT BLVD.
FREMONT,  CA  94538
Correspondent Contact SHERRIE RINNE
Regulation Number862.3610
Classification Product Code
LAF  
Date Received02/21/2001
Decision Date 05/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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