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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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