510(k) Report

FDA applicant

Bioptik Technology, Inc.

Plano, TX1 decision2006–20060 recalls

FDA records 1 decision for Bioptik Technology, Inc. (Plano, TX) in 2006: 1 510(k) clearance. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). 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 Bioptik Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bioptik Technology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bioptik Technology, 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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