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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K946116
Device Name URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD
Applicant
Chemtech Labs, Inc.
101 Ambrogio Dr.
Unit K
Gurnee,  IL  60031
Applicant Contact SHAKOOR M KHAN
Correspondent
Chemtech Labs, Inc.
101 Ambrogio Dr.
Unit K
Gurnee,  IL  60031
Correspondent Contact SHAKOOR M KHAN
Regulation Number862.1340
Classification Product Code
JIL  
Date Received12/15/1994
Decision Date 03/21/1995
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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