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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinalysis Controls (Assayed And Unassayed)
510(k) Number K810917
Device Name KOVA TROL I HUMAN URINE (DRIED)
Applicant
ICL SCIENTIFIC
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ICL SCIENTIFIC
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1660
Classification Product Code
JJW  
Date Received04/06/1981
Decision Date 04/14/1981
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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