FDA applicant
Integrated Genetics
FDA records 1 decision for Integrated Genetics (Framingham, MA) in 1987: 1 510(k) clearance. All are in product code LQO (Dna-Reagents, Campylobacter 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 Integrated Genetics’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Integrated Genetics since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Integrated Genetics’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