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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 K843938
Device Name LINEAR ENZYMATIC URIC ACID SYSTEM
Applicant
Simmler, Inc.
3755 Forest Park Ave.
St. Louis,  MO  63108
Applicant Contact CRAIG H REASON
Correspondent
Simmler, Inc.
3755 Forest Park Ave.
St. Louis,  MO  63108
Correspondent Contact CRAIG H REASON
Regulation Number862.1775
Classification Product Code
KNK  
Date Received10/09/1984
Decision Date 10/30/1984
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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