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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 K970250
Device Name CLINISTRIP
Applicant
Teco Diagnostics
4925 E. Hunter Ave.
Anaheim,  CA  92807
Applicant Contact ANDREW REAMS
Correspondent
Teco Diagnostics
4925 E. Hunter Ave.
Anaheim,  CA  92807
Correspondent Contact ANDREW REAMS
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIO   JJB  
JJR   JMT   JRE   LJX  
Date Received01/22/1997
Decision Date 04/08/1997
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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