FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Quo-Test A1c System
K Number: K180509
·
Decision Feb 16, 2019
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
248
Applicant Total
3
Review Days
354
Basic Information
- Device Name
- Quo-Test A1c System
- K Number
- K180509
- Device Class
- FDA class 2
- Clearance Type
- Dual Track
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EKF-diagnostic GmbH
- Date Received
- February 27, 2018
- Decision Date
- February 16, 2019
- 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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