PMA P850048S043
- Device
- TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P850048
- Supplement
- S043
- Product code
- MTF
- Decision date
- 2016-11-09
- Classification
- Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- Change in the manufacturing process for the conversion from a Hollow Fiber particle coupling process to a Semi-Automated Magnetic separation particle coupling process used for the paramagnetic particles in the Access Hybritech PSA.
Current openFDA PMA Record#
- Device
- TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P850048
- Supplement
- S043
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2016-11-09
- Decision code
- OK30
- Date received
- 2016-10-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the manufacturing process for the conversion from a Hollow Fiber particle coupling process to a Semi-Automated Magnetic separation particle coupling process used for the paramagnetic particles in the Access Hybritech PSA.