NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS— 510(k) K112638

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K112638 for NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS, Substantially Equivalent on 2012-03-09. Applicant: Nova Biomedical Corporation.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2011-09-09
Decision date: 2012-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walham, MA, 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.