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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 K942648
Device Name IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
Applicant
Teco Diagnostics
911 Via Rodeo
Placentia,  CA  92670
Applicant Contact K. C. CHEN
Correspondent
Teco Diagnostics
911 Via Rodeo
Placentia,  CA  92670
Correspondent Contact K. C. CHEN
Regulation Number862.1340
Classification Product Code
JIL  
Date Received06/03/1994
Decision Date 03/24/1995
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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