CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023
FDA 510(k) clearance K082275 · decided 2010-01-14
Clearance details
- K-number
- K082275
- Device name
- CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023
- Applicant
- Infopia Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-11
- Decision date
- 2010-01-14
- Days to decision
- 521 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.