FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
A1c iGear System
K Number: K142789
·
Decision Dec 16, 2014
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
2
Review Days
81
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Basic Information
- Device Name
- A1c iGear System
- K Number
- K142789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sakae Corporation
- Date Received
- September 26, 2014
- Decision Date
- December 16, 2014
- Product Code
- LCP
- Advisory Committee
- Hematology
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | FDA class 2 | Hematology |
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Other Clearances by Sakae Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K130014 | A1C GEAR SYSTEM | Apr 4, 2014 | Substantially Equivalent |