PMA P970038S034
- Device
- Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S034
- Product code
- MTG
- Decision date
- 2017-07-07
- 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
- Manufacturing change to update a specification to allow for a limited amount of flash local to the gate location (where plastic material is injected into the reaction vessel) for the Access 2 Reaction Vessels, which are used during the processing of the assays.
Current openFDA PMA Record#
- Device
- Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S034
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2017-07-07
- Decision code
- OK30
- Date received
- 2017-06-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change to update a specification to allow for a limited amount of flash local to the gate location (where plastic material is injected into the reaction vessel) for the Access 2 Reaction Vessels, which are used during the processing of the assays.