A1c iGear System
FDA 510(k) clearance K142789 · decided 2014-12-16
Clearance details
- K-number
- K142789
- Device name
- A1c iGear System
- Applicant
- Sakae Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-09-26
- Decision date
- 2014-12-16
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Fujioka, Gunma, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.