FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR
K Number: K881165
·
Decision Jul 1, 1988
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
11
Applicant Total
4
Review Days
103
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Basic Information
- Device Name
- SAKURA HEM-480 ELECTRON MICROSCOPY PROCESSOR
- K Number
- K881165
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3875
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Sakura Finetek U.S.A., Inc.
- Date Received
- March 20, 1988
- Decision Date
- July 1, 1988
- Product Code
- IEO
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| IEO | Processor, Tissue, Automated | FDA class 1 | Pathology |
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