PMA P980007S029
- Device
- ARCHITECT FREE PSA
- Applicant
- Abbott Laboratories
- PMA number
- P980007
- Supplement
- S029
- Product code
- MTG
- Decision date
- 2012-12-07
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Approval order statement
- ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.
Current openFDA PMA Record#
- Device
- ARCHITECT FREE PSA
- Applicant
- Abbott Laboratories
- PMA number
- P980007
- Supplement
- S029
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2012-12-07
- Decision code
- OK30
- Date received
- 2012-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL.