FDA applicant
Flaitron Laboratories, Inc.
FDA records 1 decision for Flaitron Laboratories, Inc. (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code KFC (Methylene Blue, Tissue Stain). 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 Flaitron Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Flaitron Laboratories, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Flaitron Laboratories, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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