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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 K863924
Device Name URIC ACID
Applicant
Tech-Co, Inc.
4378 Reilly
Troy,  MI  48098
Applicant Contact HAPPY CHEN
Correspondent
Tech-Co, Inc.
4378 Reilly
Troy,  MI  48098
Correspondent Contact HAPPY CHEN
Regulation Number862.1775
Classification Product Code
KNK  
Date Received10/08/1986
Decision Date 11/24/1986
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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