PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System— 510(k) K152599

Substantially Equivalent

Ok Biotech Co., Ltd.

FDA 510(k) clearance K152599 for PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System, Substantially Equivalent on 2016-07-20. Applicant: Ok Biotech Co., Ltd..

Clearance details

Applicant: Ok Biotech Co., Ltd.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2015-09-11
Decision date: 2016-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu City, TW

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.