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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 K110446
Device Name ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact MICHELLE LEE NEFF
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact MICHELLE LEE NEFF
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIF   DKB  
Date Received02/16/2011
Decision Date 05/03/2011
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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