HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM— 510(k) K141750
Substantially EquivalentInfopia Co, Ltd.
FDA 510(k) clearance K141750 for HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM, Substantially Equivalent on 2014-07-24. Applicant: Infopia Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Infopia Co, Ltd.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fullerton, CA, US
Recent devices under product code LCP
view allMore clearances from Infopia Co, Ltd.
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
- K132406 — ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
- K133045 — ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
- K132862 — HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.