ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT
FDA premarket approval P970038/S004 · decided 2000-02-24
Approval details
- PMA number
- P970038
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Beckman Coulter, Inc.
- Date received
- 1999-08-27
- Decision date
- 2000-02-24
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- Supplemental approval for the addition of the Access Hybritech free PSA assay on the Access Immunoassay analyzer to the other approved instrument platforms.
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510(k) clearances by this applicant
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|---|---|---|
| Access BNP II (K252169) | Beckman Coulter, Inc. | 2026-03-24 |
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| Access anti-HBc Total (K253687) | Beckman Coulter, Inc. | 2026-02-19 |
| Access anti-HAV IgM (K251995) | Beckman Coulter, Inc. | 2026-01-27 |
| Access Rubella IgG (K250588) | Beckman Coulter, Inc. | 2025-11-17 |
| iQ200 Series (K252580) | Beckman Coulter, Inc. | 2025-09-10 |
| Access anti-HAV (K243846) | Beckman Coulter, Inc. | 2025-09-09 |
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