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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Creatinine
510(k) Number K142391
Device Name Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
Applicant
ACON Laboratories, Inc.
10125 Mesa Rim Rd.
San Diego,  CA  92121
Applicant Contact QIYI XIE
Correspondent
ACON Laboratories, Inc.
10125 Mesa Rim Rd.
San Diego,  CA  92121
Correspondent Contact QIYI XIE
Regulation Number862.1225
Classification Product Code
JFY  
Subsequent Product Codes
JIR   JJW   KQO  
Date Received08/27/2014
Decision Date 12/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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