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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
Applicant Contact YVONNE E MIDDLEFELL
Correspondent
Johnson & Johnson Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14650
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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