FDA applicant
Tecan U.S., Ltd.
FDA records 10 decisions for Tecan U.S., Ltd. (Hillsborough, NC) from 1986 to 1997: 10 510(k) clearances. Most are in product codes JQW (Station, Pipetting And Diluting, For Clinical…) and JJQ (Colorimeter, Photometer, Spectrophotometer For…). 3 recalls are linked to its devices.
FDA’s records also spell it “Tecan U.S., Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tecan U.S., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Tecan U.S., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Tecan U.S., 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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