FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEP-2 CELLS
K Number: K833360
·
Decision Nov 3, 1983
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
169
Applicant Total
3
Review Days
36
Basic Information
- Device Name
- HEP-2 CELLS
- K Number
- K833360
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2280
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- BIOCON, INC.
- Date Received
- September 28, 1983
- Decision Date
- November 3, 1983
- Product Code
- KIR
- 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 |
|---|---|---|---|
| KIR | Cells, Animal And Human, Cultured | FDA class 1 | Hematology |
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