TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
FDA premarket approval P850048/S003 · decided 1989-08-21
Approval details
- PMA number
- P850048
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Beckman Coulter, Inc.
- Date received
- 1989-03-02
- Decision date
- 1989-08-21
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
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|---|---|---|
| Access BNP II (K252169) | Beckman Coulter, Inc. | 2026-03-24 |
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| Access anti-HAV IgM (K251995) | Beckman Coulter, Inc. | 2026-01-27 |
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| iQ200 Series (K252580) | Beckman Coulter, Inc. | 2025-09-10 |
| Access anti-HAV (K243846) | Beckman Coulter, Inc. | 2025-09-09 |
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