FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W
K Number: K110393
·
Decision Mar 4, 2011
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
38
Applicant Total
4
Review Days
21
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Basic Information
- Device Name
- EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W
- K Number
- K110393
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.5620
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ekf-Diagnostic GmbH
- Date Received
- February 11, 2011
- Decision Date
- March 4, 2011
- Product Code
- GKR
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GKR | System, Hemoglobin, Automated | FDA class 2 | Hematology |
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