510(k) Report

FDA applicant

Burroughs Wellcome Co.

Mchenry, IL17 decisions1977–19820 recalls

FDA records 17 decisions for Burroughs Wellcome Co. (Mchenry, IL) from 1977 to 1982: 17 510(k) clearances. Most are in product codes GTZ (Antisera, All Groups, Streptococcus Spp.) and JHI (Visual, Pregnancy Hcg, Prescription Use). 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, clinical chemistry panel, where it files most

How often FDA has decided Burroughs Wellcome Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Burroughs Wellcome Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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