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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 K081938
Device Name ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
Applicant
GENZYME DIAGNOSTICS P.E.I. INC.
700 WATTS AVENUE
CHARLOTTETOWN, PRIN ED ISLAND,  CA C1E 2B9
Applicant Contact PENNY J WHITE
Correspondent
GENZYME DIAGNOSTICS P.E.I. INC.
700 WATTS AVENUE
CHARLOTTETOWN, PRIN ED ISLAND,  CA C1E 2B9
Correspondent Contact PENNY J WHITE
Regulation Number862.3030
Classification Product Code
LDP  
Date Received07/08/2008
Decision Date 05/01/2009
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
Recalls CDRH Recalls
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