PMA P910007S049
- Device
- ARCHITECT TOTAL PSA (LN 6C06)
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S049
- Product code
- MTF
- Decision date
- 2015-08-13
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.
Current openFDA PMA Record#
- Device
- ARCHITECT TOTAL PSA (LN 6C06)
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S049
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2015-08-13
- Decision code
- OK30
- Date received
- 2015-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACE THE POLYPROPYLENE RESIN USED IN THE MANUFACTURE OF ARCHITECT REACTION VESSELS.