TANDEM(R)-E AFP
FDA premarket approval P840035/S003 · decided 1988-04-29
Approval details
- PMA number
- P840035
- Supplement
- S003
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TANDEM(R)-E AFP
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Applicant
- Beckman Coulter, Inc.
- Date received
- 1986-04-03
- Decision date
- 1988-04-29
- Days to decision
- 757 days
- Decision code
- APPR
- Product code
- LOJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- San Diego, CA
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