# Abbott Diagnostics Mfg., Inc.

- Location (FDA's records): Irving, TX
- FDA decisions: 1 (1999–1999): 1 510(k) clearance
- Product codes: CKB (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 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
- Trace America, Inc.: 1 (https://510kreport.com/company/trace-america)

## Recent decisions
- K991010: ACP (May 19, 1999)

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