PMA P820060S009
- Device
- Abbott Axsym Afp (list 7a48)
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S009
- Decision date
- 1995-12-26
Current openFDA PMA Record
- Device
- ABBOTT AXSYM AFP (LIST 7A48)
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S009
- Product code
- LOJ
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Decision date
- 1995-12-26
- Decision code
- APPR
- Date received
- 1995-11-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION OF THE POTENCY TEST FOR THE ANTI-AFP: ALKALINE PHOSPHATASE CONJUGATE