FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES
K Number: K061150
·
Decision Jul 6, 2006
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
376
Applicant Total
21
Review Days
72
Basic Information
- Device Name
- SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES
- K Number
- K061150
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SYSMEX AMERICA, INC.
- Date Received
- April 25, 2006
- Decision Date
- July 6, 2006
- Product Code
- GKZ
- 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K141681 | SYSMEX XN SERIES | Dec 5, 2014 | Substantially Equivalent |
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| K091313 | SYSMEX MODEL XT-4000I | Mar 30, 2010 | Substantially Equivalent |
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| K081890 | SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER | Oct 10, 2008 | Substantially Equivalent |
| K081610 | SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER | Aug 29, 2008 | Substantially Equivalent |
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