FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RH VIEWBOX
K Number: K792306
·
Decision Dec 4, 1979
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
2
Review Days
18
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Basic Information
- Device Name
- RH VIEWBOX
- K Number
- K792306
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.9185
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Tekpro
- Date Received
- November 16, 1979
- Decision Date
- December 4, 1979
- Product Code
- KSY
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| KSY | Boxes, View, Blood Grouping | FDA class 1 | Hematology |
Other Clearances by Tekpro
| K Number | Device Name | ||
|---|---|---|---|
| K782050 | PRINTER, TEK PRO TEK TALLY II | Jan 3, 1979 | Substantially Equivalent |