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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
510(k) Number K943436
Device Name URINE REAGENT STRIPS-8 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 Number862.1115
Classification Product Code
JJB  
Subsequent Product Codes
CDM   CEN   JIR   JMT  
Date Received07/18/1994
Decision Date 04/24/1995
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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