GENSTRIP TEST STRIP MODEL 100-201— 510(k) K103542

Substantially Equivalent

Shasta Technologies, LLC

FDA 510(k) clearance K103542 for GENSTRIP TEST STRIP MODEL 100-201, Substantially Equivalent on 2012-11-30. Applicant: Shasta Technologies, LLC.

Clearance details

Applicant: Shasta Technologies, LLC
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2010-12-02
Decision date: 2012-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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.