PMA P910007S040
- Device
- ARCHITECT TOTAL PSA
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S040
- Product code
- MTF
- Decision date
- 2013-11-26
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Approval order statement
- REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
Current openFDA PMA Record#
- Device
- ARCHITECT TOTAL PSA
- Applicant
- Abbott Laboratories
- PMA number
- P910007
- Supplement
- S040
- Product code
- MTF
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Decision date
- 2013-11-26
- Decision code
- OK30
- Date received
- 2013-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACEMENT OF A QUALITY CONTROL TEST WITH A NEW QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.