FDA applicant

Teco Diagnostics

Anaheim, CA55 decisions1993–20170 recalls

FDA records 55 decisions for Teco Diagnostics (Anaheim, CA) from 1993 to 2017: 55 510(k) clearances. Most are in product codes JIL (Method, Enzymatic, Glucose (Urinary…) and JHI (Visual, Pregnancy Hcg, Prescription Use). Its devices cite 15 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Teco Diagnostics, Inc.”.

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 Teco Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

3in 2017

2007high 3 (2011) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Teco Diagnostics

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?