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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K150330
Device Name 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 Number862.1645
Classification Product Code
JIR  
Subsequent Product Code
JFY  
Date Received02/10/2015
Decision Date 04/30/2015
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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