FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSMEX R-500
K Number: K001683
·
Decision Aug 21, 2000
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
3
Review Days
81
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Basic Information
- Device Name
- SYSMEX R-500
- K Number
- K001683
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sysmex Corporation of America
- Date Received
- June 1, 2000
- Decision Date
- August 21, 2000
- Product Code
- GKL
- 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 |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | FDA class 2 | Hematology |
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