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FDA 510(k)

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer

K-Number: K182038 · 2018-12-10

ApplicantYd Diagnostics Corporation
Decision Date2018-12-10
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer is a medical device manufactured by Yd Diagnostics Corporation. It received FDA 510(k) clearance on 2018-12-10 under approval number K182038. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer?

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer is a medical device that received FDA 510(k) clearance on 2018-12-10. It is manufactured by Yd Diagnostics Corporation. The 510(k) number is K182038.

When was URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer approved by the FDA?

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer received FDA 510(k) clearance on 2018-12-10, under approval number K182038.

What company makes URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer?

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer is manufactured by Yd Diagnostics Corporation.

What is the FDA product code for URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer?

The FDA product code for URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer is JFY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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