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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urease, Photometric, Urea Nitrogen
510(k) Number K961196
Device Name EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14650 -0882
Applicant Contact CHARLES C MORGANSON
Correspondent
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
100 INDIGO CREEK DR.
ROCHESTER,  NY  14650 -0882
Correspondent Contact CHARLES C MORGANSON
Regulation Number862.1770
Classification Product Code
CDN  
Date Received03/27/1996
Decision Date 05/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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