TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY
FDA premarket approval P850048/S014 · decided 1999-06-16
Approval details
- PMA number
- P850048
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 1999-05-19
- Decision date
- 1999-06-16
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- Approval for an alternate manufacturing site located at Beckman Coulter, Inc., 1000 Lake Hazeltine Dr., Chaska, MN 55318.
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