FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HFF GENCELLS
K Number: K850990
·
Decision Apr 12, 1985
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
366
Applicant Total
3
Review Days
32
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Basic Information
- Device Name
- HFF GENCELLS
- K Number
- K850990
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Bioassay Systems Research Corp.
- Date Received
- March 11, 1985
- Decision Date
- April 12, 1985
- Product Code
- KIT
- 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 |
|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | FDA class 1 | Hematology |
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