PMA P820060S010
- Device
- Abbott Axsym Afp (list 7a48)
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S010
- Decision date
- 1996-12-02
Current openFDA PMA Record
- Device
- ABBOTT AXSYM AFP (LIST 7A48)
- Applicant
- Abbott Laboratories
- PMA number
- P820060
- Supplement
- S010
- Product code
- LOJ
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Decision date
- 1996-12-02
- Decision code
- APPR
- Date received
- 1996-11-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MOVING THE NORMAL MOUSE SERUM CONTAINED IN THE CONJUGATE COMPONENT TO THE ASSAY DILUENT COMPONENT