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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 K892331
Device Name ENZYMATIC UREA NITROGEN REAGENT SET
Applicant
AMERICAN MONITOR CORP.
P.O. BOX 68505
INDIANAPOLIS,  IN  46268
Applicant Contact JENNIFER LINE
Correspondent
AMERICAN MONITOR CORP.
P.O. BOX 68505
INDIANAPOLIS,  IN  46268
Correspondent Contact JENNIFER LINE
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received04/05/1989
Decision Date 06/20/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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