Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Infopia with 20 510(k) clearances. The most recent is a 510(k) clearance dated Sep 28, 2016: BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitori….
| Date | Record | Source |
|---|---|---|
| Sep 28, 2016 | BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemK160365 · NBW | 510(k) clearances |
| Aug 26, 2015 | GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring SystemK150274 · NBW | 510(k) clearances |
| Jul 24, 2014 | HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEMK141750 · LCP | 510(k) clearances |
| Apr 18, 2014 | ELEMENTV BLOOD GLUCOSE MONITORING SYSTEMK132406 · NBW | 510(k) clearances |
| Apr 10, 2014 | ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEMK133045 · NBW | 510(k) clearances |
| Dec 12, 2013 | HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMK132862 · NBW | 510(k) clearances |
| Dec 5, 2013 | GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMK132966 · NBW | 510(k) clearances |
| Jul 31, 2013 | GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMK130181 · NBW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
