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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Uric, Uricase (Colorimetric)
510(k) Number K862208
Device Name KING DIAGNOSTICS URIC ACID TEST
Applicant
King Diagnostics, Inc.
6856 Hawthorn Park Dr.
Indianapolis,  IN  46220
Applicant Contact FRANCES K LOH
Correspondent
King Diagnostics, Inc.
6856 Hawthorn Park Dr.
Indianapolis,  IN  46220
Correspondent Contact FRANCES K LOH
Regulation Number862.1775
Classification Product Code
KNK  
Date Received06/10/1986
Decision Date 07/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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