FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LINISTAIN SLS
K Number: K890984
·
Decision Apr 4, 1989
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
0
Applicant Total
5
Review Days
36
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Basic Information
- Device Name
- LINISTAIN SLS
- K Number
- K890984
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3800
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Shandon, Inc.
- Date Received
- February 27, 1989
- Decision Date
- April 4, 1989
- Product Code
- KIO
- 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 |
|---|---|---|---|
| KIO | Slide Stainer, Immersion Type | FDA class 1 | Pathology |