Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)

Indicator Method, Protein Or Albumin (urinary, Non-quant.)

ACON Laboratories, Inc.

The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Mission Urinalysis Reagent Strips (microalbumin/creatinine).

Pre-market Notification Details

Device IDK150330
510k NumberK150330
Device Name:Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
ClassificationIndicator Method, Protein Or Albumin (urinary, Non-quant.)
Applicant ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego,  CA  92121
ContactQiyi Xie
CorrespondentQiyi Xie
ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego,  CA  92121
Product CodeJIR  
CFR Regulation Number862.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-10
Decision Date2015-04-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10722066004392 K150330 000

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