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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
510(k) Number K862806
Device Name URINE DIAGNOSTIC REAGENT STRIPS
Applicant
Amatech International, Inc.
2400 Fountainview
Suite 200
Houston,  TX  77057
Applicant Contact JERRY Y PARK
Correspondent
Amatech International, Inc.
2400 Fountainview
Suite 200
Houston,  TX  77057
Correspondent Contact JERRY Y PARK
Regulation Number862.1115
Classification Product Code
JJB  
Date Received07/23/1986
Decision Date 12/04/1986
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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