FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ABX ERYTROL
K Number: K050721
·
Decision Jun 1, 2005
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
19
Review Days
72
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Basic Information
- Device Name
- ABX ERYTROL
- K Number
- K050721
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Horiba Abx
- Date Received
- March 21, 2005
- Decision Date
- June 1, 2005
- Product Code
- JPK
- 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | FDA class 2 | Hematology |
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