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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 K012257
Device Name EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
Applicant
Syva Co.
20400 Mariani Ave.
Cupertino,  CA  95014
Applicant Contact SUSAN L COLLINS
Correspondent
Syva Co.
20400 Mariani Ave.
Cupertino,  CA  95014
Correspondent Contact SUSAN L COLLINS
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Code
LAF  
Date Received07/18/2001
Decision Date 08/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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