FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK
K Number: K770076
·
Decision Mar 22, 1977
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
20
Applicant Total
3
Review Days
68
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Basic Information
- Device Name
- BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK
- K Number
- K770076
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3800
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Jack W. Kindberg
- Date Received
- January 13, 1977
- Decision Date
- March 22, 1977
- Product Code
- KPA
- Advisory Committee
- Pathology
- Review Advisory Committee
- HE
- 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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