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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, Cocaine And Cocaine Metabolites
510(k) Number K011162
Device Name MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
Applicant
Syva Co., Dade Behring, Inc.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Applicant Contact SUSAN COLLINS
Correspondent
Syva Co., Dade Behring, Inc.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Correspondent Contact SUSAN COLLINS
Regulation Number862.3250
Classification Product Code
DIO  
Date Received04/16/2001
Decision Date 05/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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