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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 K860109
Device Name ENZYMATIC UREA NITROGEN REAGENT SET
Applicant
TECHNOSTICS INTL.
P.O. BOX 94090
WASHINGTON,  MI  48094
Applicant Contact SUSAN RENEHAN
Correspondent
TECHNOSTICS INTL.
P.O. BOX 94090
WASHINGTON,  MI  48094
Correspondent Contact SUSAN RENEHAN
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received01/13/1986
Decision Date 02/06/1986
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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