Abbott Laboratories
FDA 510(k) & PMA Approved Devices — 34 products
Total Devices34
Categories23
Latest FDA decision2026-05-11
SEC Filings: 1 filings on record. Latest: 8-K (2026-07-16). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P120008 | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | LOK | 2026-05-11 | View |
| 510(k) | K252424 | Anti-HCV Next | MZO | 2026-04-28 | View |
| PMA | P910007 | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer | MTF | 2026-02-23 | View |
| PMA | P980007 | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions | MTG | 2026-02-12 | View |
| 510(k) | K243500 | ARCHITECT iGentamicin | LCD | 2025-07-09 | View |
| 510(k) | K243168 | Alinity i Rubella IgG | LFX | 2025-06-20 | View |
| PMA | P110029 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2025-04-03 | View |
| PMA | P060035 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2025-04-03 | View |
| PMA | P080023 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2025-04-03 | View |
| PMA | P210003 | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | LOM | 2025-04-03 | View |
| 510(k) | K243283 | Alinity h-series System | GKZ | 2025-02-20 | View |
| 510(k) | K233932 | Alinity i Toxo IgM | LGD | 2024-08-30 | View |
| 510(k) | K232669 | TBI | QAT | 2023-09-29 | View |
| 510(k) | K222850 | HAVAb IgG II | LOL | 2023-08-10 | View |
| 510(k) | K220031 | Alinity h-series System | GKZ | 2023-08-04 | View |
| 510(k) | K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | GJS | 2023-07-14 | View |
| 510(k) | K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | DHA | 2023-06-05 | View |
| 510(k) | K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series | DHA | 2023-05-19 | View |
| 510(k) | K223602 | Traumatic brain injury (TBI) test | QAT | 2023-03-02 | View |
| 510(k) | K220949 | Architect CMV IgG | LFZ | 2022-10-27 | View |
No matching devices.
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