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FDA PMA

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

PMA Number: P170037 · 2019-01-30

ApplicantOpko Diagnostics, LLC
Decision Date2019-01-30
PMA NumberP170037
Product CodeMTF
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeIM

Device Summary

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer is the device name listed in this FDA 510(k) record. The listed applicant is Opko Diagnostics, LLC. It received FDA 510(k) clearance on 2019-01-30. The device is classified under product code MTF. It was reviewed by the IM advisory panel.

Frequently Asked Questions

What is the Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer?

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer is a medical device that received FDA 510(k) clearance on 2019-01-30. The listed applicant is Opko Diagnostics, LLC.

When did Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer receive FDA 510(k) clearance?

The clearance date for Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer can be found in the official FDA records.

Who is the listed applicant for Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer?

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

What is the FDA product code for Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer?

The FDA product code for Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer is MTF.

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.

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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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