← Every applicant
Abbott Laboratories FDA Approvals
0 new drug approvals and 17 device clearances on file. Matched by name to ABT.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Anti-HCV Next510(k)Sep 23, 2026Microbiology |
| Anti-HCV Next510(k)Apr 28, 2026Microbiology |
| ARCHITECT iGentamicin510(k)Jul 9, 2025Clinical Toxicology |
| Alinity i Rubella IgG510(k)Jun 20, 2025Microbiology |
| Alinity h-series System510(k)Feb 20, 2025Hematology |
| Alinity i Toxo IgM510(k)Aug 30, 2024Microbiology |
| TBI510(k)Sep 29, 2023Immunology |
| HAVAb IgG II510(k)Aug 10, 2023Microbiology |
| Alinity h-series System510(k)Aug 4, 2023Hematology |
| i-STAT PTplus Cartridge with the i-STAT 1 System510(k)Jul 14, 2023Hematology |
| Alinity i Total ß-hCG Reagent Kit, GLP systems Track510(k)Jun 5, 2023Clinical Chemistry |
| Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series510(k)May 19, 2023Clinical Chemistry |
| Traumatic brain injury (TBI) test510(k)Mar 2, 2023Immunology |
| Architect CMV IgG510(k)Oct 27, 2022Microbiology |
| ARCHITECT Toxo IgG510(k)May 19, 2022Microbiology |
| GLP systems Track510(k)Mar 10, 2022Clinical Chemistry |
| i-STAT TBI Plasma cartridge with the i-STAT Alinity System510(k)Jan 8, 2021Immunology |