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FDA PMA

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

Numéro PMA : P910065 · 2019-06-18

DemandeurTosoh Bioscience, Inc.
Date de décision2019-06-18
Numéro PMAP910065
Code produitMTF
Classe de dispositifClasse 3
Spécialité médicaleU
Comité consultatifIM

Résumé du dispositif

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 Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2019-06-18. The device is classified under product code MTF. It was reviewed by the IM advisory panel.

Questions fréquentes

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 2019-06-18. The listed applicant is Tosoh Bioscience, Inc..

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 Tosoh Bioscience, Inc. 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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Source officielle

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