FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEST KIT, IIF-AMA
K Number: K790295
·
Decision May 25, 1979
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
26
Applicant Total
47
Review Days
105
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Basic Information
- Device Name
- TEST KIT, IIF-AMA
- K Number
- K790295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5090
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Medica Corp.
- Date Received
- February 9, 1979
- Decision Date
- May 25, 1979
- Product Code
- DBM
- 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 |
|---|---|---|---|
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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