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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 K912028
Device Name URIC ACID (URICASE) REAGENT, UNIVERSAL
Applicant
Enzyme Technology, Inc.
415 Howe Ave.
Shelton,  CT  06484
Applicant Contact PETER R KLAMKA
Correspondent
Enzyme Technology, Inc.
415 Howe Ave.
Shelton,  CT  06484
Correspondent Contact PETER R KLAMKA
Regulation Number862.1775
Classification Product Code
KNK  
Date Received05/08/1991
Decision Date 12/18/1991
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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