PMA P190022S002

Device: The 4Kscore Test
Applicant: Opko Health, Inc.
PMA number: P190022
Supplement: S002
Product code: QRF
Decision date: 2024-01-30
Classification: Immunology
Generic name: Multi-analyte test system with algorithmic analysis for detection of prostate cancer
Approval order statement: Approval for software changes made to the B2 Laboratory Information System (LIS) and Specimen Processing Module (SPM) of the 4Kscore Test.

Current openFDA PMA Record#

Device: The 4Kscore Test
Applicant: Opko Health, Inc.
PMA number: P190022
Supplement: S002
Product code: QRF
Generic name: Multi-analyte test system with algorithmic analysis for detection of prostate cancer
Decision date: 2024-01-30
Decision code: APPR
Date received: 2023-11-01
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for software changes made to the B2 Laboratory Information System (LIS) and Specimen Processing Module (SPM) of the 4Kscore Test.