PMA P970038S012
- Device
- ACCESS HYBRITECH FREE PSA ASSAY
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S012
- Product code
- MTG
- Decision date
- 2008-08-13
- Classification
- Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Approval order statement
- APPROVAL FOR THE ADDITION OF A CALIBRATION TRACEABLE TO THE WORLD HEALTH ORGANIZATION 1ST INTERNATIONAL REFERENCE PREPARATION 96/668 FOR THE ACCESS HYBRITECH FREE PSA ASSAY
Current openFDA PMA Record#
- Device
- ACCESS HYBRITECH FREE PSA ASSAY
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S012
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2008-08-13
- Decision code
- APPR
- Date received
- 2008-05-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF A CALIBRATION TRACEABLE TO THE WORLD HEALTH ORGANIZATION 1ST INTERNATIONAL REFERENCE PREPARATION 96/668 FOR THE ACCESS HYBRITECH FREE PSA ASSAY