PMA P970038S046

Device: Access Hybritech free PSA
Applicant: Beckman Coulter, Inc.
PMA number: P970038
Supplement: S046
Product code: MTG
Decision date: 2025-05-15
Classification: Immunology
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: Migration of the Access Hybritech free PSA to the DxI 9000 Access Immunoassay Analyzer.

Current openFDA PMA Record#

Device: Access Hybritech free PSA
Applicant: Beckman Coulter, Inc.
PMA number: P970038
Supplement: S046
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2025-05-15
Decision code: APPR
Date received: 2024-08-02
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Migration of the Access Hybritech free PSA to the DxI 9000 Access Immunoassay Analyzer.