FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HISTO-CENTER II
K Number: K792095
·
Decision Nov 20, 1979
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
0
Applicant Total
4
Review Days
34
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Basic Information
- Device Name
- HISTO-CENTER II
- K Number
- K792095
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Thermolyne Corp.
- Date Received
- October 17, 1979
- Decision Date
- November 20, 1979
- Product Code
- IDW
- 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 |
|---|---|---|---|
| IDW | Dispensers, Paraffin | FDA class 1 | Pathology |