FDA applicant

Standard Diagnostics, Inc.

Great Neck, NY3 decisions2003–20100 recalls

FDA records 3 decisions for Standard Diagnostics, Inc. (Great Neck, NY) from 2003 to 2010: 3 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Its devices cite 3 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2010

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Standard Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Standard”

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

Standard Textile Co., Inc. 23 Standard Bariatrics 12 Standard Imaging, Inc. 10 Standard Welders Supply Co. 3 The Standard Co., Ltd. 2 Standard Surgical 1 Standard Engineering 1 Standard Scientific, Inc. 1

Standard 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 “Standard”