FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MRC-5 CULTURE CELL
K Number: K933925
·
Decision Mar 29, 1994
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
169
Applicant Total
20
Review Days
231
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Basic Information
- Device Name
- MRC-5 CULTURE CELL
- K Number
- K933925
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2280
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neogenex
- Date Received
- August 10, 1993
- Decision Date
- March 29, 1994
- 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 |
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Other Clearances by Neogenex
| K Number | Device Name | ||
|---|---|---|---|
| K965047 | MINK LUNG CELL CULTURE | Feb 4, 1997 | Substantially Equivalent |
| K960909 | H292 CELL CULTURE | May 30, 1996 | Substantially Equivalent |
| K943887 | HUMAN NEWBORN FORESKIN CELL CULTURE | Nov 28, 1994 | Substantially Equivalent |
| K943888 | MDCK CELL CULTURE | Nov 28, 1994 | Substantially Equivalent |
| K943891 | RD CULTURE CELL | Nov 28, 1994 | Substantially Equivalent |
| K943885 | PRIMARY RABBIT KIDNEY CELL CULTURE | Nov 28, 1994 | Substantially Equivalent |
| K943889 | VERO CELL CULTURE | Nov 28, 1994 | Substantially Equivalent |
| K943886 | BGM CELL CULTURE | Nov 28, 1994 | Substantially Equivalent |
| K943890 | WI38 CELL CULTURE | Nov 28, 1994 | Substantially Equivalent |
| K943884 | PRIMARY MONKEY KIDNEY CELL CULTURE | Nov 28, 1994 | Substantially Equivalent |