HEMOCUE HBA1C 501— 510(k) K121366
Substantially EquivalentInfopia Co, Ltd.
FDA 510(k) clearance K121366 for HEMOCUE HBA1C 501, Substantially Equivalent on 2012-09-07. 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
- Great Neck, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.