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FDA 510(k)

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device

K-Number: K182062 · 2018-10-30

ApplicantSysmex America, Inc.
Decision Date2018-10-30
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex America, Inc.. It received FDA 510(k) clearance on 2018-10-30 under 510(k) number K182062. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device?

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is Sysmex America, Inc.. The 510(k) number is K182062.

When did Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device receive FDA 510(k) clearance?

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device received FDA 510(k) clearance on 2018-10-30, under 510(k) number K182062.

Who is the listed applicant for Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device?

The FDA 510(k) record lists Sysmex America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device?

The FDA product code for Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device is JOY.

Other records listing Sysmex America, Inc. as applicant

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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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