FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERMO SCIENTIFIC CYTO-CAL COUNT TUBES
K Number: K090810
·
Decision Sep 18, 2009
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
107
Review Days
177
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Basic Information
- Device Name
- THERMO SCIENTIFIC CYTO-CAL COUNT TUBES
- K Number
- K090810
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microgenics Corp.
- Date Received
- March 25, 2009
- Decision Date
- September 18, 2009
- 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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