FDA applicant

SEKISUI Diagnostics, LLC

San Diego, CA6 decisions2012–20250 recalls

FDA records 6 decisions for SEKISUI Diagnostics, LLC (San Diego, CA) from 2012 to 2025: 6 510(k) clearances. Most are in product codes PSZ (Devices Detecting Influenza A, B, And C Virus…) and KTN (System, Test, Infectious Mononucleosis). Its devices cite 5 predicates, 1 of them its own earlier devices. 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 SEKISUI Diagnostics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — SEKISUI Diagnostics, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like SEKISUI Diagnostics, LLC’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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Other applicant names beginning “SEKISUI”

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

Sekisui Diagnostics P.E.I., Inc. 6 Sekisui Medical Co., Ltd. 1

SEKISUI Diagnostics, LLC

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “SEKISUI”