FDA applicant
Giles Scientific, Inc.
FDA records 4 decisions for Giles Scientific, Inc. (New York, NY) from 1985 to 1994: 4 510(k) clearances. Most are in product codes KZK (Reader, Zone, Automated) and JTZ (Culture Media, Antimicrobial Susceptibility…). 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 Giles Scientific, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Giles Scientific, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Giles Scientific, 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