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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, Acid Reduction Of Ferric Ion
510(k) Number K812313
Device Name SANDARE URIC ACID PROCEDURE
Applicant
Sandare Chemical Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sandare Chemical Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1775
Classification Product Code
LFQ  
Date Received08/17/1981
Decision Date 09/01/1981
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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