TANDEM(R)-E AFP
FDA premarket approval P840035/S006 · decided 1987-08-05
Approval details
- PMA number
- P840035
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TANDEM(R)-E AFP
- Generic name
- KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
- Applicant
- Beckman Coulter, Inc.
- Date received
- 1987-02-04
- Decision date
- 1987-08-05
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- LOJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- San Diego, CA
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