FDA applicant

Quantai Biotronics, Inc.

Tustin, CA3 decisions1988–19900 recalls

FDA records 3 decisions for Quantai Biotronics, Inc. (Tustin, CA) from 1988 to 1990: 3 510(k) clearances. All are in product code CGA (Glucose Oxidase, Glucose). 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 Quantai Biotronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quantai Biotronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Quantai Biotronics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?