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- OYMProstrate Cancer Genes Nucleic Acid Amplification Test System3Product Code
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4Kscore Test
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- OPKO Health, Inc.
- Trade Name
- 4Kscore Test
- Generic Name
- Multi-analyte test system with algorithmic analysis for detection of prostate cancer
- Decision Date
- 12/7/2021
- Days to Decision
- 823 days
- Decision Code
- APPR
- FDA Decision
- Approval