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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Acetaminophen
510(k) Number K110726
Device Name ROCHE ACETAMINOPHEN ASSAY
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250 -0416
Applicant Contact ANGELO PEREIRA
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250 -0416
Correspondent Contact ANGELO PEREIRA
Regulation Number862.3030
Classification Product Code
LDP  
Date Received03/16/2011
Decision Date 12/23/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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