FDA applicant
Burroughs Wellcome Co.
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
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.
Planning a device like Burroughs Wellcome Co.’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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