FDA applicant
Enteric Products, Inc.
FDA records 2 decisions for Enteric Products, Inc. (Stony Brook, NY) from 1999 to 2000: 2 510(k) clearances. All are in product code LYR (Helicobacter Pylori). 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 Enteric Products, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Enteric Products, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Enteric Products, 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) ReportOther applicant names beginning “Enteric”
FDA records each applicant name separately; these may or may not be the same firm.