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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K994380
Device Name CEDIA DAU AMPHASSURE ASSAY
Applicant
MICROGENICS CORP.
46360 FREMONT BLVD.
FREMONT,  CA  94538
Applicant Contact NEAL BELLET
Correspondent
MICROGENICS CORP.
46360 FREMONT BLVD.
FREMONT,  CA  94538
Correspondent Contact NEAL BELLET
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Code
DKB  
Date Received12/27/1999
Decision Date 05/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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