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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 K954933
Device Name EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14650 -0882
Applicant Contact YVONNE E MIDDLEFELL
Correspondent
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14650 -0882
Correspondent Contact YVONNE E MIDDLEFELL
Regulation Number862.3030
Classification Product Code
LDP  
Date Received10/27/1995
Decision Date 12/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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