510(k) Report

FDA applicant

Ab Biodisk

Solna, SE64 decisions1991–200836 recalls

FDA records 64 decisions for Ab Biodisk (Solna, SE) from 1991 to 2008: 64 510(k) clearances. Most are in product codes JWY (Manual Antimicrobial Susceptibility Test Systems) and LTX (Discs, Elution). 36 recalls are linked to its devices, 4 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Ab Biodisk’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

15in 2022

2015: 5, 4 Class I2016: 112017: 52022: 15
2007high 15 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ab Biodisk by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JWYManual Antimicrobial Susceptibility Test Systems61decisions
  • LTXDiscs, Elution2decisions
  • NGZSusceptibility Test Plate, Antifungal1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K913459The E Test, ModificationAb Biodisk · 19911cites it

What has FDA decided for it lately?

  • K081325Etest Doripenem - Antimicrobial Susceptibility Test - Mic at 0.002-32 UG/MLAb Biodisk · 20081 recall
  • K052366Etest Tigecycline Gram Positive and Gram Negative Aerobic Bacteria, Streptococcus SPP. and Anaerobic BacteriaAb Biodisk · 2005
  • K042392DaptomycinAb Biodisk · 2004
  • K042390Etest for GemifloxacinAb Biodisk · 2004
  • K040560Etest for Antifungal Suscepttibility TestingAb Biodisk · 20041 recall
  • K021445Etest Cefditoren for S. Pneumoniae and H. InfluenzaeAb Biodisk · 2002
  • K020748Etest ErtapenemAb Biodisk · 20022 recalls
  • K010363Etest MeropenemAb Biodisk · 20012 recalls

All 64 as Ab Biodisk →

What has been recalled?

36 recalls linked to its devices; the latest:

  • K970210Etest Clinical Amikacin AK 256 US S30, Catalog 412218Nov 9, 2022Class II
  • K913459Etest Clinical Amoxi/Clav 2/1 XL 256 US S30, Catalog 412252Nov 9, 2022Class II
  • K981135Etest Clinical Benzylpenicil PG 256 US S30, Catalog 412262Nov 9, 2022Class II
  • K020748Etest Clinical Ertapenem Etp 32 US S30, Catalog 412331Nov 9, 2022Class II
  • K913459Etest Clinical Erythromycin EM 256 US S30, Catalog 412333Nov 9, 2022Class II
  • K010363Etest Clinical Meropenem MP 32 US S30, Catalog 412401Nov 9, 2022Class II