TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
FDA premarket approval P850048/S006 · decided 1990-11-05
Approval details
- PMA number
- P850048
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 1990-10-02
- Decision date
- 1990-11-05
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
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