PMA P970038S029
- Device
- ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S029
- Product code
- MTG
- Decision date
- 2015-03-20
- 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 AN ALTERNATE VENDOR OF THE POLYPROPYLENE RESIN USED TO MANUFACTURE THE UNICEL DXL REACTION VESSELS.
Current openFDA PMA Record#
- Device
- ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S029
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2015-03-20
- Decision code
- APPR
- Date received
- 2014-11-04
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ALTERNATE VENDOR OF THE POLYPROPYLENE RESIN USED TO MANUFACTURE THE UNICEL DXL REACTION VESSELS.