FDA applicant

Biotope, Inc.

Redmond, WA7 decisions1991–19910 recalls

FDA records 7 decisions for Biotope, Inc. (Redmond, WA) in 1991: 7 510(k) clearances. Most are in product codes CFR (Hexokinase, Glucose) and JJQ (Colorimeter, Photometer, Spectrophotometer For…). 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 Biotope, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biotope, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Biotope, Inc.

Which product codes does it file in?

What has FDA decided for it lately?