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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 K914158
Device Name URIC ACID REAGENT SET
Applicant
Tech Intl. Co.
1856 Starr-Batt Dr.
Rochester Hills,  MI  48309
Correspondent
Tech Intl. Co.
1856 Starr-Batt Dr.
Rochester Hills,  MI  48309
Regulation Number862.1775
Classification Product Code
KNK  
Date Received09/17/1991
Decision Date 02/21/1992
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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