# Ab Biodisk

- Location (FDA's records): Solna, SE
- FDA decisions: 64 (1991–2008): 64 510(k) clearances
- Product codes: JWY (61), LTX (2), NGZ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 36 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Becton Dickinson Microbiology Systems: 1 (https://510kreport.com/company/becton-dickinson-microbiology-systems)

## Its most-cited devices
- K913459: The E Test, Modification (1991), cited by 1

## Recent decisions
- K081325: Etest Doripenem - Antimicrobial Susceptibility Test - Mic at 0.002-32 UG/ML (Jul 24, 2008)
- K052366: Etest Tigecycline Gram Positive and Gram Negative Aerobic Bacteria, Streptococcus SPP. and Anaerobic Bacteria (Oct 13, 2005)
- K042392: Daptomycin (Dec 13, 2004)
- K042390: Etest for Gemifloxacin (Nov 19, 2004)
- K040560: Etest for Antifungal Suscepttibility Testing (Jul 27, 2004)
- K021445: Etest Cefditoren for S. Pneumoniae and H. Influenzae (Jun 6, 2002)
- K020748: Etest Ertapenem (Apr 29, 2002)
- K010363: Etest Meropenem (Apr 9, 2001)

Source page: https://510kreport.com/company/ab-biodisk