FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APERIO EPATHOLOGY EIHC IVD SYSTEM
K Number: K141109
·
Decision Jul 29, 2014
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
11
Applicant Total
3
Review Days
91
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Basic Information
- Device Name
- APERIO EPATHOLOGY EIHC IVD SYSTEM
- K Number
- K141109
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Leica Biosystems Imaging, Inc.
- Date Received
- April 29, 2014
- Decision Date
- July 29, 2014
- Product Code
- NOT
- 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 |
|---|---|---|---|
| NOT | Microscope, Automated, Image Analysis, Operator Intervention | FDA class 2 | Hematology |
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