# Abbott Laboratories Diagnostics Division

- Location (FDA's records): Abbott Park, IL
- FDA decisions: 4 (2019–2024): 4 510(k) clearances
- Product codes: MMI (3), CJE (1)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)

## Its most-cited devices
- K202525: Alinity i STAT High Sensitivity Troponin-I (2022), cited by 1
- K191595: ARCHITECT STAT High Sensitivity Troponin-I (2019), cited by 1

## Recent decisions
- K240468: Alkaline Phosphatase (Oct 16, 2024)
- K230994: Alinity i STAT High Sensitivity Troponin-I (May 4, 2023)
- K202525: Alinity i STAT High Sensitivity Troponin-I (May 19, 2022)
- K191595: ARCHITECT STAT High Sensitivity Troponin-I (Sep 13, 2019)

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