FDA applicant

Biochemical Diagnostic, Inc.

Edgewood, NY5 decisions1984–20122 recalls

FDA records 5 decisions for Biochemical Diagnostic, Inc. (Edgewood, NY) from 1984 to 2012: 5 510(k) clearances. Most are in product codes DIF (Drug Mixture Control Materials) and DKE (Reagents, Test, Tetrahydrocannabinol). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are 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 Diagnostic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2024

2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Biochemical Diagnostic, 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 “Biochemical”

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

Biochemical Trade, Inc. 20 Biochemical Diagnostics, Inc. 2 Biochemical Sciences, Inc. 1

Biochemical Diagnostic, 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?

What has been recalled?

Other applicant names beginning “Biochemical”