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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 K043028
Device Name EMIT II PLUS ECSTASY ASSAY
Applicant
Dade Behring, Inc.
P.O. Box 6101
M/S 514
Newark,  DE  19714 -6101
Applicant Contact YUK-TING LEWIS
Correspondent
Dade Behring, Inc.
P.O. Box 6101
M/S 514
Newark,  DE  19714 -6101
Correspondent Contact YUK-TING LEWIS
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIF   DLJ  
Date Received11/03/2004
Decision Date 01/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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