510(k) K180509
K180509 is an FDA 510(k) premarket notification submitted by Ekf-Diagnostic GmbH for the device "Quo-Test A1c System". The FDA issued a decision of Substantially Equivalent on February 16, 2019. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Ekf-Diagnostic GmbH has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2019
- Date Received
- February 27, 2018
- Clearance Type
- Dual Track
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Glycosylated Hemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7470
- Review Panel
- HE
- Submission Type