FDA applicant

Biochemical Diagnostics, Inc.

Edgewood, NY2 decisions2013–20160 recalls

FDA records 2 decisions for Biochemical Diagnostics, Inc. (Edgewood, NY) from 2013 to 2016: 2 510(k) clearances. All are in product code DIF (Drug Mixture Control Materials). Its devices cite 2 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 Biochemical Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Biochemical Diagnostics, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biochemical 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 “Biochemical”

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

Biochemical Trade, Inc. 20 Biochemical Diagnostic, Inc. 5 Biochemical Sciences, Inc. 1

Biochemical 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 “Biochemical”