FDA applicant
Bioptik Technology, Inc.
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
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.
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.
See the 510(k) Report