HYBRITECH(R) STRATUS(R) PSA ASSAY FLOUROMETRIC
FDA premarket approval P850048/S007 · decided 1992-05-21
Approval details
- PMA number
- P850048
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HYBRITECH(R) STRATUS(R) PSA ASSAY FLOUROMETRIC
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 1991-07-01
- Decision date
- 1992-05-21
- Days to decision
- 325 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
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