PMA P970038S036
- Device
- Access Hybritech free PSA Reagents/Calibrator Kit Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S036
- Product code
- MTG
- Decision date
- 2017-10-24
- 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
- Addition of a supplier manufacturing site for the production of the UniCel DxI reaction vessels.
Current openFDA PMA Record#
- Device
- Access Hybritech free PSA Reagents/Calibrator Kit Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S036
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2017-10-24
- Decision code
- OK30
- Date received
- 2017-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a supplier manufacturing site for the production of the UniCel DxI reaction vessels.