PMA P840035S004
- Device
- TANDEM(R)-E AFP
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P840035
- Supplement
- S004
- Product code
- LOJ
- Decision date
- 1986-09-02
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
Current openFDA PMA Record
- Device
- TANDEM(R)-E AFP
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P840035
- Supplement
- S004
- Product code
- LOJ
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Decision date
- 1986-09-02
- Decision code
- APPR
- Date received
- 1986-08-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename