FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE
K Number: K971508
·
Decision Sep 17, 1997
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
169
Applicant Total
3
Review Days
145
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Basic Information
- Device Name
- RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE
- K Number
- K971508
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2280
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Whittaker, Inc., A Cambrex Co.
- Date Received
- April 25, 1997
- Decision Date
- September 17, 1997
- Product Code
- KIR
- Advisory Committee
- Hematology
- Review Advisory Committee
- MI
- 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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