FDA applicant
Lab Ability, Inc.
FDA records 5 decisions for Lab Ability, Inc. (Mchenry, IL) from 1981 to 1983: 5 510(k) clearances. Most are in product codes JTO (Discs, Strips And Reagents, Microorganism…) and LIA (Antigens, All Groups, Shigella Spp.). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Lab Ability, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Lab Ability, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Lab Ability, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report