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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitroprusside, Ketones (Urinary, Non-Quant.)
510(k) Number K170587
Device Name On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
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 Number862.1435
Classification Product Code
JIN  
Date Received02/28/2017
Decision Date 07/06/2017
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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