IMMULITE® PSA, IMMULITE® 2000 PSA, IMMULITE® Third Generation PSA, IMMULITE® 2000 Third Generation PSA
FDA premarket approval P930027/S027 · decided 2023-08-30
Approval details
- PMA number
- P930027
- Supplement
- S027
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IMMULITE® PSA, IMMULITE® 2000 PSA, IMMULITE® Third Generation PSA, IMMULITE® 2000 Third Generation PSA
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2022-03-21
- Decision date
- 2023-08-30
- Days to decision
- 527 days
- Decision code
- APPR
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- Approval for the change in labeling to include a limitation regarding interference from the drug STRENSIQ.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Atellica CH Acetaminophen 2 (ACTM) (K261364) | Siemens Healthcare Diagnostics, Inc. | 2026-07-24 |
| Atellica CH Diazo Total Bilirubin (D_TBil) (K251998) | Siemens Healthcare Diagnostics, Inc. | 2026-02-27 |
| Atellica® IM TSH3-Ultra II (TSH3ULII) (K251543) | Siemens Healthcare Diagnostics, Inc. | 2026-02-06 |
| Atellica IM Total PSA II (tPSAII) (K251630) | Siemens Healthcare Diagnostics, Inc. | 2026-01-05 |
| ADVIA Centaur Anti-Thyroglobulin II (aTgII) (K250816) | Siemens Healthcare Diagnostics, Inc. | 2025-12-04 |
| ADVIA Centaur Anti-Thyroid Peroxidase II (K250250) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Atellica IM Thyroglobulin (Tg) (K242981) | Siemens Healthcare Diagnostics, Inc. | 2025-06-20 |
| Atellica® CH Creatinine_3 (Crea3) (K242685) | Siemens Healthcare Diagnostics, Inc. | 2024-12-04 |