FDA applicant

Accu-Stat Diagnostics, Inc.

Lake Forest, CA3 decisions2004–20040 recalls

FDA records 3 decisions for Accu-Stat Diagnostics, Inc. (Lake Forest, CA) in 2004: 3 510(k) clearances. Most are in product codes LDJ (Enzyme Immunoassay, Cannabinoids) and MVO (Kit, Test, Multiple, Drugs Of Abuse, Over The…). Its devices cite 3 predicates, 0 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, clinical toxicology panel, where it files most

How often FDA has decided Accu-Stat Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Accu-Stat Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Accu-Stat Diagnostics, Inc.’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 “Accu-Stat”

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

Accu-Line 4 Accu Science Corp. 2 Accu-Med Corp. 1 Accu-Speed, Incorporated 1 Accu-Path 1

Accu-Stat Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Accu-Stat”