FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VERSABLOT
K Number: K884258
·
Decision Dec 14, 1988
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
20
Applicant Total
3
Review Days
64
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Basic Information
- Device Name
- VERSABLOT
- K Number
- K884258
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3800
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- American Bionetics, Inc.
- Date Received
- October 11, 1988
- Decision Date
- December 14, 1988
- Product Code
- KPA
- Advisory Committee
- Pathology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| KPA | Slide Stainer, Automated | FDA class 1 | Pathology |
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