FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IIF-APCA TEST KIT
K Number: K790759
·
Decision Jul 30, 1979
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
47
Review Days
104
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Basic Information
- Device Name
- IIF-APCA TEST KIT
- K Number
- K790759
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5110
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Medica Corp.
- Date Received
- April 17, 1979
- Decision Date
- July 30, 1979
- Product Code
- DBJ
- 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 |
|---|---|---|---|
| DBJ | Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
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