FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ELECTRO IMMUNO ASSAY KIT
K Number: K770150
·
Decision Feb 1, 1977
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
5
Applicant Total
30
Review Days
8
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Basic Information
- Device Name
- ELECTRO IMMUNO ASSAY KIT
- K Number
- K770150
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4500
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Millipore Corp.
- Date Received
- January 24, 1977
- Decision Date
- February 1, 1977
- Product Code
- JZS
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JZS | Electrophoresis Instrumentation | FDA class 1 | Immunology |
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