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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 K922969
Device Name KING DIAGNOSTICS UREA NITROGEN REAGENT
Applicant
KING DIAGNOSTICS, INC.
6856 HAWTHORN PARK DR.
INDIANAPOLIS,  IN  46220
Applicant Contact FRANCES LOH
Correspondent
KING DIAGNOSTICS, INC.
6856 HAWTHORN PARK DR.
INDIANAPOLIS,  IN  46220
Correspondent Contact FRANCES LOH
Regulation Number862.1770
Classification Product Code
CDN  
Date Received06/19/1992
Decision Date 10/13/1992
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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