FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MELANOCYTE GROWTH MEDIUM (MGM)
K Number: K890700
·
Decision Feb 24, 1989
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
366
Applicant Total
4
Review Days
14
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Basic Information
- Device Name
- MELANOCYTE GROWTH MEDIUM (MGM)
- K Number
- K890700
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Clonetics Corp.
- Date Received
- February 10, 1989
- Decision Date
- February 24, 1989
- Product Code
- KIT
- 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 |
|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | FDA class 1 | Hematology |
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