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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, Phosphotungstate Reduction
510(k) Number K792403
Device Name ELVI URIC ACID-COLORIMETRIC METHOD
Applicant
VOLU SOL MEDICAL INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
VOLU SOL MEDICAL INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1775
Classification Product Code
CDH  
Date Received11/26/1979
Decision Date 12/07/1979
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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