510(k) K103553— LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION

Substantially Equivalent

Bionostics, Inc.

Clearance details

Applicant: Bionostics, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2010-12-03
Decision date: 2011-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Devens, MA, US

Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.