PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS— 510(k) K051213

Substantially Equivalent

Abbott Laboratories, Inc.

FDA 510(k) clearance K051213 for PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS, Substantially Equivalent on 2005-05-27. Applicant: Abbott Laboratories, Inc..

Clearance details

Applicant: Abbott Laboratories, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2005-05-12
Decision date: 2005-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Alameda, CA, 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.