Quo-Test A1c System
FDA 510(k) clearance K180509 · decided 2019-02-16
Clearance details
- K-number
- K180509
- Device name
- Quo-Test A1c System
- Applicant
- Ekf-Diagnostic GmbH
- Decision
- Substantially Equivalent
- Date received
- 2018-02-27
- Decision date
- 2019-02-16
- Days to decision
- 354 days
- Clearance type
- Dual Track
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Barleben, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.