PMA P820060S012
- Device
- Abbott Axsym Afp
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S012
- Decision date
- 1997-10-29
Current openFDA PMA Record
- Device
- ABBOTT AXSYM AFP
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S012
- Product code
- LOJ
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Decision date
- 1997-10-29
- Decision code
- APPR
- Date received
- 1997-10-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes in the labeling regarding limitations of the procedure