FDA applicant
Drew Scientific, Ltd.
FDA records 9 decisions for Drew Scientific, Ltd. (London W4 4ph Uk, GB) from 1992 to 2007: 9 510(k) clearances. Most are in product codes LCP (Assay, Glycosylated Hemoglobin) and GKZ (Counter, Differential Cell). Its devices cite 6 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Drew Scientific, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Drew Scientific, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2007
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Drew Scientific, Ltd.’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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