FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RK GENCELLS
K Number: K851563
·
Decision May 10, 1985
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
169
Applicant Total
9
Review Days
24
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Basic Information
- Device Name
- RK GENCELLS
- K Number
- K851563
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2280
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Genus Diagnostics
- Date Received
- April 16, 1985
- Decision Date
- May 10, 1985
- Product Code
- KIR
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| KIR | Cells, Animal And Human, Cultured | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KIR), ordered by most recent decision date.
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FRESH CELLS LLC-MK2
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Other Clearances by Genus Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K854974 | HSV IDR | Mar 7, 1986 | Substantially Equivalent |
| K852206 | HEP-2 GENCELLS | Jun 4, 1985 | Substantially Equivalent |
| K852204 | MCCOY GENCELLS | Jun 4, 1985 | Substantially Equivalent |
| K852205 | RMK GENCELLS CULTURE SYSTEM | Jun 4, 1985 | Substantially Equivalent |
| K851927 | VERO GENCELLS | May 20, 1985 | Substantially Equivalent |
| K851928 | HEK GENCELLS | May 20, 1985 | Substantially Equivalent |
| K851561 | WI-38 GENCELLS | May 10, 1985 | Substantially Equivalent |
| K851562 | MRC-5 GENCELLS | May 10, 1985 | Substantially Equivalent |