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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 K031004
Device Name SYVA EMIT II PLUS AMPHETAMINES ASSAY
Applicant
Dade Behring, Inc.
500 Gbc Dr.
Newark,  DE  19702
Applicant Contact RADAMES RIESGO
Correspondent
Dade Behring, Inc.
500 Gbc Dr.
Newark,  DE  19702
Correspondent Contact RADAMES RIESGO
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received03/31/2003
Decision Date 06/06/2003
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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