Atellica® IM Alpha Fetoprotein (AFP) Assay
FDA premarket approval P930036/S017 · decided 2021-08-25
Approval details
- PMA number
- P930036
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Atellica® IM Alpha Fetoprotein (AFP) Assay
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2021-07-26
- Decision date
- 2021-08-25
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Changing primary reagent label to one common label for Atellica IM and ADVIA Centaur ReadyPacks.
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510(k) clearances by this applicant
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|---|---|---|
| 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 |