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FDA PMA

P2psa

PMA Number: P090026 · 2025-06-16

ApplicantBeckman Coulter, Inc.
Decision Date2025-06-16
PMA NumberP090026
Product CodeOYA
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeIM

Device Summary

P2psa is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-06-16. The device is classified under product code OYA. It was reviewed by the IM advisory panel.

Frequently Asked Questions

What is the P2psa?

P2psa is a medical device that received FDA 510(k) clearance on 2025-06-16. The listed applicant is Beckman Coulter, Inc..

When did P2psa receive FDA 510(k) clearance?

The clearance date for P2psa can be found in the official FDA records.

Who is the listed applicant for P2psa?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for P2psa?

The FDA product code for P2psa is OYA.

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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