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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K974337
Device Name IL TEST UREA NITROGEN
Applicant
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
LEXINGTON,  MA  02173
Applicant Contact CAROL MARBLE
Correspondent
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
LEXINGTON,  MA  02173
Correspondent Contact CAROL MARBLE
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received11/18/1997
Decision Date 12/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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