P2psa
Номер PMA: P090026 · 2025-06-16
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ЗаявительBeckman Coulter, Inc.
Дата решения2025-06-16
Номер PMAP090026
Код продуктаOYA
Класс устройстваКласс 3
Медицинская специализацияU
Консультативный комитетIM
Описание устройства
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.
Часто задаваемые вопросы
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.
Официальный источник
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