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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 K020175
Device Name URS-IG (GLUCOSE TEST)
Applicant
Teco Diagnostics
1268 . Lakeview Ave.
Anaheim,  CA  92807
Applicant Contact OLIVIA CHEN
Correspondent
Teco Diagnostics
1268 . Lakeview Ave.
Anaheim,  CA  92807
Correspondent Contact OLIVIA CHEN
Regulation Number862.1340
Classification Product Code
JIL  
Date Received01/17/2002
Decision Date 03/21/2002
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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