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FDA PMA

PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

PMA Number: P000027 · 2026-04-29

ApplicantRoche Diagnostics Corp.
Decision Date2026-04-29
PMA NumberP000027
Product CodeLTJ
Device ClassClass 2
Medical SpecialtyI
Regulation Number21 CFR 8
Advisory CommitteeIM

Device Summary

PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2026-04-29. The device is classified under product code LTJ. It was reviewed by the IM advisory panel.

Frequently Asked Questions

What is the PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS?

PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS is a medical device that received FDA 510(k) clearance on 2026-04-29. The listed applicant is Roche Diagnostics Corp..

When did PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS receive FDA 510(k) clearance?

The clearance date for PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS can be found in the official FDA records.

Who is the listed applicant for PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS?

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

What is the FDA product code for PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS?

The FDA product code for PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS is LTJ.

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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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