FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
K Number: K050709
·
Decision Mar 8, 2006
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
22
Applicant Total
22
Review Days
355
Basic Information
- Device Name
- RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
- K Number
- K050709
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7415
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- WALLAC OY
- Date Received
- March 18, 2005
- Decision Date
- March 8, 2006
- Product Code
- GKA
- 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 |
|---|---|---|---|
| GKA | Abnormal Hemoglobin Quantitation | FDA class 2 | Hematology |
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