FDA applicant
Labtronix Corp.
FDA records 2 decisions for Labtronix Corp. (Mchenry, IL) in 1981: 2 510(k) clearances. Most are in product codes GKL (Counter, Cell, Automated (Particle Counter)) and GLG (Platelet Counting, Manual). 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 Labtronix Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Labtronix Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Labtronix Corp.’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