FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER
K Number: K882881
·
Decision Jul 28, 1988
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
2
Applicant Total
4
Review Days
17
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Basic Information
- Device Name
- SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER
- K Number
- K882881
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Sakura Finetek U.S.A., Inc.
- Date Received
- July 11, 1988
- Decision Date
- July 28, 1988
- Product Code
- KES
- 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 |
|---|---|---|---|
| KES | Coverslips, Microscope Slide | FDA class 1 | Pathology |
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