PMA P190022S001

Device: 4Kscore Test
Applicant: Opko Health, Inc.
PMA number: P190022
Supplement: S001
Product code: QRF
Decision date: 2024-01-08
Classification: Immunology
Generic name: Multi-analyte test system with algorithmic analysis for detection of prostate cancer
Approval order statement: Approval to transfer the manufacturing site for the preparation of two (iPSA and hK2) of the four 4Kscore Test reagents from the original site, OPKO Diagnostics, LLC., Woburn, Massachusetts, to a new manufacturing site, BioReference Health, LLC., Elmwood Park, New Jersey (BioReference).

Current openFDA PMA Record#

Device: 4Kscore Test
Applicant: Opko Health, Inc.
PMA number: P190022
Supplement: S001
Product code: QRF
Generic name: Multi-analyte test system with algorithmic analysis for detection of prostate cancer
Decision date: 2024-01-08
Decision code: APPR
Date received: 2023-08-24
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to transfer the manufacturing site for the preparation of two (iPSA and hK2) of the four 4Kscore Test reagents from the original site, OPKO Diagnostics, LLC., Woburn, Massachusetts, to a new manufacturing site, BioReference Health, LLC., Elmwood Park, New Jersey (BioReference).