PMA P970038S015
- Device
- ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S015
- Product code
- MTG
- Decision date
- 2012-02-17
- 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 CHANGE IN POLYPROPYLENE RESIN USED FOR MANUFACTURING OF THE REAGENT PACK CONTAINER.
Current openFDA PMA Record#
- Device
- ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S015
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2012-02-17
- Decision code
- APPR
- Date received
- 2011-12-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE CHANGE IN POLYPROPYLENE RESIN USED FOR MANUFACTURING OF THE REAGENT PACK CONTAINER.