510(k) Report

FDA applicant

Celltech Diagnostics, Ltd.

Suite 11oo, Washington, DC1 decision1991–19910 recalls

FDA records 1 decision for Celltech Diagnostics, Ltd. (Suite 11oo, Washington, DC) in 1991: 1 510(k) clearance. All are in product code MHI (Giardia Spp.). 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 Celltech Diagnostics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Celltech Diagnostics, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Celltech Diagnostics, 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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