GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K051285
Substantially EquivalentInfopia Co, Ltd.
FDA 510(k) clearance K051285 for GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2005-08-02. Applicant: Infopia Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Infopia Co, Ltd.
- Product code
- Code CGA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anyang Kvunggi, KR
Recent devices under product code CGA
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view all- K160365 — BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System
- K150274 — GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System
- K141750 — HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
- K132406 — ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
- K133045 — ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
Adverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
Source: openFDA MAUDE database, through . 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.