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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 K940469
Device Name URINE REAGENT STRIP-3 PARAMETERS
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  
Subsequent Product Codes
CEN   JIR  
Date Received02/02/1994
Decision Date 09/09/1994
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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