510(k) Report

FDA applicant

Gull Laboratories, Inc.

Salt Lake City, UT57 decisions1977–19990 recalls

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, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

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.

FIG. 1 — Gull Laboratories, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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