510(k) Report

FDA applicant

Agilent Technologies Singapore (International) Pte, Ltd.

Singapore2 decisions1998–20051 recall

FDA records 2 decisions for Agilent Technologies Singapore (International) Pte, Ltd. (Singapore) from 1998 to 2005: 2 original PMA approvals. Most are in product codes MVC (System, Test, Her-2/Neu, Ihc) and MVD (System, Test, Her-2/Neu, Nucleic Acid Or Serum). 1 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, pathology panel, where it files most

How often FDA has decided Agilent Technologies Singapore (International) Pte, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Agilent Technologies Singapore (International) Pte, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Agilent Technologies Singapore (International) Pte, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Agilent”

FDA records each applicant name separately; these may or may not be the same firm.