FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCANSCOPE XT SYSTEM
K Number: K080254
·
Decision Oct 31, 2008
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
5
Review Days
274
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Basic Information
- Device Name
- SCANSCOPE XT SYSTEM
- K Number
- K080254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aperio Technologies
- Date Received
- January 31, 2008
- Decision Date
- October 31, 2008
- Product Code
- OEO
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| OEO | Automated Digital Image Manual Interpretation Microscope | FDA class 2 | Hematology |
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