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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 K853888
Device Name AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &
Applicant
American Research Products Co.
P.O. Box 21009
South Euclid,  OH  44121
Applicant Contact TIMOTHY J BELCASTRO
Correspondent
American Research Products Co.
P.O. Box 21009
South Euclid,  OH  44121
Correspondent Contact TIMOTHY J BELCASTRO
Regulation Number862.1225
Classification Product Code
CGX  
Date Received09/19/1985
Decision Date 10/15/1985
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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