PMA P840035S003
- Device
- Tandem(r)-e Afp
- Applicant
- BECKMAN COULTER, INC.
- PMA number
- P840035
- Supplement
- S003
- Decision date
- 1988-04-29
Current openFDA PMA Record
- Device
- TANDEM(R)-E AFP
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P840035
- Supplement
- S003
- Product code
- LOJ
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Decision date
- 1988-04-29
- Decision code
- APPR
- Date received
- 1986-04-03
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename