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FDA PMA

ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)

PMA Number: P990055 · 2025-07-16

ApplicantSiemens Healthcare Diagnostics
Decision Date2025-07-16
PMA NumberP990055
Product CodeNAF
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeIM

Device Summary

ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2025-07-16. The device is classified under product code NAF. It was reviewed by the IM advisory panel.

Frequently Asked Questions

What is the ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)?

ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) is a medical device that received FDA 510(k) clearance on 2025-07-16. The listed applicant is Siemens Healthcare Diagnostics.

When did ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) receive FDA 510(k) clearance?

The clearance date for ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) can be found in the official FDA records.

Who is the listed applicant for ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)?

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

What is the FDA product code for ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)?

The FDA product code for ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) is NAF.

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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