FDA applicant

Zer Hitech

Alpharetta, GA1 decision2003–20030 recalls

FDA records 1 decision for Zer Hitech (Alpharetta, GA) in 2003: 1 510(k) clearance. All are in product code JHI (Visual, Pregnancy Hcg, Prescription Use). 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 Zer Hitech’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zer Hitech since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Zer Hitech

Which product codes does it file in?

What has FDA decided for it lately?