# Abbott Laboratories

- Location (FDA's records): Abbott Park, IL
- FDA decisions: 920 (1976–2026): 890 510(k) clearances and 30 original PMA approvals
- Names in FDA's records: Abbott Laboratories (908); Abbott Laboratories, Inc. (12)
- Product codes: FRN (67), FPA (30), GKZ (24), KNT (23), JHI (15), CIG (15), CDP (13), JJE (13), NBW (12), LGD (12), FPB (11), JLW (10)
- 510(k) review time since 2016: median 95 days, against 128 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 223 (79 its own); citations of its devices by later devices: 275 (79 its own)
- Recalls linked to its devices: 477 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boehringer Mannheim Corp.: 31 (https://510kreport.com/company/boehringer-mannheim)
- Roche Diagnostic Systems, Inc.: 20 (https://510kreport.com/company/roche-diagnostic-systems)
- Syva Co.: 9 (https://510kreport.com/company/syva)
- Roche Diagnostics Corp.: 8 (https://510kreport.com/company/roche-diagnostics)
- Medisense, Inc.: 7 (https://510kreport.com/company/medisense)
- Crestat Diagnostics, Inc.: 6 (https://510kreport.com/company/crestat-diagnostics)
- Abbott Diabetes Care, Inc.: 5 (https://510kreport.com/company/abbott-diabetes-care)
- Abbott Diagnostics: 4 (https://510kreport.com/company/abbott-diagnostics)

## Firms that cite its devices most
- Hospira, Inc.: 25 (https://510kreport.com/company/hospira)
- Beckman Coulter, Inc.: 10 (https://510kreport.com/company/beckman-coulter)
- Beckman Instruments, Inc.: 9 (https://510kreport.com/company/beckman-instruments)
- Dade Behring, Inc.: 9 (https://510kreport.com/company/dade-behring)
- Boehringer Mannheim Corp.: 9 (https://510kreport.com/company/boehringer-mannheim)
- Abbott Ireland Diagnostics Division: 8 (https://510kreport.com/company/abbott-ireland-diagnostics-division)
- Abbott Diabetes Care, Inc.: 8 (https://510kreport.com/company/abbott-diabetes-care)
- Ortho-Clinical Diagnostics, Inc.: 7 (https://510kreport.com/company/ortho-clinical-diagnostics)

## Its most-cited devices
- K882233: TDX (R) Digoxin NXT (1988), cited by 7
- K904226: 'Tdxflx Analyzer (1990), cited by 6
- P890025: TD Cyclosporine and Metabolites Serum Assay (1989), cited by 6
- K992858: Abbott Axsym Homocysteine (1999), cited by 5
- P970007: Imx Tacrolimus II Assay (1997), cited by 5
- P820060: Abbott Afp-Eia Diagnostic Kit for Cancer (1983), cited by 4

## Recent decisions
- K262156: Anti-HCV Next (Sep 23, 2026)
- K252424: Anti-HCV Next (Apr 28, 2026)
- K243500: ARCHITECT iGentamicin (Jul 9, 2025)
- K243168: Alinity i Rubella IgG (Jun 20, 2025)
- K243283: Alinity h-series System (Feb 20, 2025)
- K233932: Alinity i Toxo IgM (Aug 30, 2024)
- K232669: TBI (Sep 29, 2023)
- K222850: HAVAb IgG II (Aug 10, 2023)

Source page: https://510kreport.com/company/abbott-laboratories