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FDA 510(k)

UASure II Blood Uric Acid Monitoring System

K-Number: K242209 · 2025-04-04

ApplicantApex BioTechnology Corp.
Decision Date2025-04-04
Product CodePTC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UASure II Blood Uric Acid Monitoring System is a medical device manufactured by Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2025-04-04 under approval number K242209. The device is classified under product code PTC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UASure II Blood Uric Acid Monitoring System?

UASure II Blood Uric Acid Monitoring System is a medical device that received FDA 510(k) clearance on 2025-04-04. It is manufactured by Apex BioTechnology Corp.. The 510(k) number is K242209.

When was UASure II Blood Uric Acid Monitoring System approved by the FDA?

UASure II Blood Uric Acid Monitoring System received FDA 510(k) clearance on 2025-04-04, under approval number K242209.

What company makes UASure II Blood Uric Acid Monitoring System?

UASure II Blood Uric Acid Monitoring System is manufactured by Apex BioTechnology Corp..

What is the FDA product code for UASure II Blood Uric Acid Monitoring System?

The FDA product code for UASure II Blood Uric Acid Monitoring System is PTC.

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Related Devices (Code: PTC)

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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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