HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC
FDA premarket approval P850048/S008 · decided 1992-03-24
Approval details
- PMA number
- P850048
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 1991-12-16
- Decision date
- 1992-03-24
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
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