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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 K050801
Device Name URISCAN OPTIMA II URINE ANALYZER
Applicant
YD DIAGNOSTICS
707 FOOTHILL BLVD. STE. 200
LA CANADA,  CA  91011
Applicant Contact JERRI HOI
Correspondent
YD DIAGNOSTICS
707 FOOTHILL BLVD. STE. 200
LA CANADA,  CA  91011
Correspondent Contact JERRI HOI
Regulation Number862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIO   JIR  
JJB   JMT   JRE   KQO   LJX  
Date Received03/30/2005
Decision Date 04/20/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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