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FDA 510(k)

Q-Pad Test System

K-Number: K231465 · 2023-12-06

ApplicantQurasense
Decision Date2023-12-06
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Q-Pad Test System is the device name listed in this FDA 510(k) record. The listed applicant is Qurasense. It received FDA 510(k) clearance on 2023-12-06 under 510(k) number K231465. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q-Pad Test System?

Q-Pad Test System is a medical device that received FDA 510(k) clearance on 2023-12-06. The listed applicant is Qurasense. The 510(k) number is K231465.

When did Q-Pad Test System receive FDA 510(k) clearance?

Q-Pad Test System received FDA 510(k) clearance on 2023-12-06, under 510(k) number K231465.

Who is the listed applicant for Q-Pad Test System?

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

What is the FDA product code for Q-Pad Test System?

The FDA product code for Q-Pad Test System is LCP.

Related Clinical Trials

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.

NCT07281599Evaluation of the Q-Pad hrHPV Test System for Identifying PrecancerRECRUITING

Related Devices (Code: LCP)

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.

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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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