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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K880843
Device Name CREATININE REAGENT SET (KINETIC)
Applicant
Tech-Neal Scientific, Inc.
817 Oakwood Dr.
Westmont,  IL  60559
Applicant Contact ARUN SANGHAVI
Correspondent
Tech-Neal Scientific, Inc.
817 Oakwood Dr.
Westmont,  IL  60559
Correspondent Contact ARUN SANGHAVI
Regulation Number862.1225
Classification Product Code
CGX  
Date Received02/26/1988
Decision Date 04/05/1988
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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