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Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer — Opko Health, Inc. (PMA P190022)

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer — Opko Health, Inc. (PMA P190022) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer; Applicant: Opko Health, In

Device nameMulti-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
ApplicantOpko Health, Inc.
Clearance trackPMA
Submission numberP190022
DecisionAPPR
Decision date2025-07-25
Date received2025-01-28
Product codeQRF
Device class3
Medical specialtyUnknown
Applicant locationFL
SourceopenFDA device

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