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FDA PMA

Multi-analyte test system with algorithmic analysis for detection of prostate cancer

PMA Number: P200048 · 2026-07-28

ApplicantCleveland Diagnostics, Inc.
Decision Date2026-07-28
PMA NumberP200048
Product CodeQRF
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeIM

Device Summary

Multi-analyte test system with algorithmic analysis for detection of prostate cancer is the device name listed in this FDA 510(k) record. The listed applicant is Cleveland Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-07-28. The device is classified under product code QRF. It was reviewed by the IM advisory panel.

Frequently Asked Questions

What is the Multi-analyte test system with algorithmic analysis for detection of prostate cancer?

Multi-analyte test system with algorithmic analysis for detection of prostate cancer is a medical device that received FDA 510(k) clearance on 2026-07-28. The listed applicant is Cleveland Diagnostics, Inc..

When did Multi-analyte test system with algorithmic analysis for detection of prostate cancer receive FDA 510(k) clearance?

The clearance date for Multi-analyte test system with algorithmic analysis for detection of prostate cancer can be found in the official FDA records.

Who is the listed applicant for Multi-analyte test system with algorithmic analysis for detection of prostate cancer?

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

What is the FDA product code for Multi-analyte test system with algorithmic analysis for detection of prostate cancer?

The FDA product code for Multi-analyte test system with algorithmic analysis for detection of prostate cancer is QRF.

Related Clinical Trials

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Official Source

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

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