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FDA-PMA

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

PMA-Nummer: P170037 · 2019-01-30

AntragstellerOpko Diagnostics, LLC
Entscheidungsdatum2019-01-30
PMA-NummerP170037
ProduktcodeMTF
GeräteklasseKlasse 3
Medizinische FachrichtungU
BeratungsausschussIM

Produktübersicht

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.

Häufig gestellte Fragen

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.

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