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EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM - Ekf-Diagnostic Hemoglobin Microcuvettes (modified Curvette W
FDA 510(k)Class II (US FDA 510(k))
510(k) K110393
Identifiers
- 510(k) Number
- K110393 FDA 510(k)
- FDA Product Code
- GKR FDA 510(k)
- Models / Variants
- Ekf-Diagnostic Hemoglobin Microcuvettes (modified Curvette W FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5620 FDA 510(k)
- Regulation Number
- 864.5620 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM - Ekf-Diagnostic Hemoglobin Microcuvettes (modified Curvette W by EKF-diagnostic GmbH — Class II…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110393 | Class II | Active |
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Manufacturer
- Manufacturer
- EKF-diagnostic GmbH
Sources (1)
- FDA 510(k) K110393 24 fields · synced Jun 18, 2026