BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS— 510(k) K013203

Substantially Equivalent

Polymer Technology Systems, Inc.

FDA 510(k) clearance K013203 for BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS, Substantially Equivalent on 2001-11-16. Applicant: Polymer Technology Systems, Inc..

Clearance details

Applicant: Polymer Technology Systems, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2001-09-25
Decision date: 2001-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Adverse events under product code NBW

product code NBW

Death: 18
Injury: 4,740
Malfunction: 42,679
Other: 6
Total: 47,443

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.