FDA applicant
Gull Laboratories, Inc.
FDA records 57 decisions for Gull Laboratories, Inc. (Salt Lake City, UT) from 1977 to 1999: 57 510(k) clearances. Most are in product codes LGC (Enzyme Linked Immunoabsorbent Assay, Herpes…) and LGD (Enzyme Linked Immunoabsorbent Assay…). 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 Gull Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Gull Laboratories, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Gull Laboratories, 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