FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CELL CULTURE LINES
K Number: K780869
·
Decision Aug 14, 1978
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
169
Applicant Total
3
Review Days
76
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Basic Information
- Device Name
- CELL CULTURE LINES
- K Number
- K780869
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2280
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Bioassay Systems Research Corp.
- Date Received
- May 30, 1978
- Decision Date
- August 14, 1978
- Product Code
- KIR
- Advisory Committee
- Hematology
- Review Advisory Committee
- TX
- 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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