HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC
FDA premarket approval P850048/S009 · decided 1994-08-25
Approval details
- PMA number
- P850048
- Supplement
- S009
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 1992-06-29
- Decision date
- 1994-08-25
- Days to decision
- 787 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
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