# Abbott Diagnostics

- Location (FDA's records): Mountain View, CA
- FDA decisions: 28 (1981–1997): 28 510(k) clearances
- Product codes: GKL (7), GKZ (6), JJQ (3), GIF (2), GKH (2), KHO (1), GGK (1), JGS (1), JPK (1), LTK (1), MJZ (1), GJZ (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 9 (0 its own)
- Recalls linked to its devices: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Laboratories: 2 (https://510kreport.com/company/abbott-laboratories)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)

## Firms that cite its devices most
- Abbott Laboratories: 4 (https://510kreport.com/company/abbott-laboratories)
- Abx Diagnostics: 2 (https://510kreport.com/company/abx-diagnostics)
- Bayer Healthcare, LLC: 1 (https://510kreport.com/company/bayer-healthcare)
- Horiba Abx: 1 (https://510kreport.com/company/horiba-abx)
- Mwi, Inc.: 1 (https://510kreport.com/company/mwi)

## Its most-cited devices
- K961439: Abbott Cell-Dyn 4000 System (1996), cited by 5
- K870233: Cell-Dyn 1600 Multiparameter Auto. Hema. Analyzer (1987), cited by 2
- K890491: Cell-Dyn 3000 Multi-Parameter Hematology Analyer (1989), cited by 2

## Recent decisions
- K964185: IMX CA 125 (Nov 4, 1997)
- K972182: Abbott Strep a Controls (Aug 13, 1997)
- K961439: Abbott Cell-Dyn 4000 System (Oct 18, 1996)
- K890491: Cell-Dyn 3000 Multi-Parameter Hematology Analyer (Apr 18, 1989)
- K881242: Cell-Dyn Rapid-Lyse and Hemogloblin (Apr 21, 1988)
- K881130: Cell-Dyn Isotonic Diluent (Mar 31, 1988)
- K873347: Cell-Dyn Diff. Screen Isotonic Diluent (Sep 9, 1987)
- K873348: Cell-Dyn Diff Screen, Auto. & Semi Auto. Lytic AG. (Sep 9, 1987)

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