TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
FDA premarket approval P970038/S003 · decided 1999-06-16
Approval details
- PMA number
- P970038
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Beckman Coulter, Inc.
- Date received
- 1999-05-14
- Decision date
- 1999-06-16
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- Approval for an alternate manufacturing site located at Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318.
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