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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 the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2025-04-04 under 510(k) 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. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K242209.

When did UASure II Blood Uric Acid Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for UASure II Blood Uric Acid Monitoring System?

The FDA 510(k) record lists Apex BioTechnology Corp. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Apex BioTechnology Corp. as applicant

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Related Devices (Code: PTC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181675FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring SystemTaidoc Technology CorporationK160990Nova Max Uric Acid Monitoring SystemNova Biomedical Corporation

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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