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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 K973142
Device Name DBEST REAGENT STRIP FOR URINALYSIS
Applicant
Ameritek, Inc.
7030 35th Ave., NE
Seattle,  WA  98115
Applicant Contact K.C. YEE
Correspondent
Ameritek, Inc.
7030 35th Ave., NE
Seattle,  WA  98115
Correspondent Contact K.C. YEE
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIO   JIR  
JJB   JMT   JRE   LJX  
Date Received08/21/1997
Decision Date 10/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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