FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT
K Number: K871194
·
Decision Apr 20, 1987
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
23
Applicant Total
3
Review Days
27
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Basic Information
- Device Name
- I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT
- K Number
- K871194
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Cronus
- Date Received
- March 24, 1987
- Decision Date
- April 20, 1987
- Product Code
- DBL
- 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 |
|---|---|---|---|
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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