CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023— 510(k) K082275
Substantially EquivalentInfopia Co, Ltd.
FDA 510(k) clearance K082275 for CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023, Substantially Equivalent on 2010-01-14. 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
- Traditional
- Location
- Great Neck, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.