FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOANTIBODY SCREEN TEST SYSTEM
K Number: K831358
·
Decision Jun 15, 1983
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
26
Applicant Total
135
Review Days
50
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Basic Information
- Device Name
- AUTOANTIBODY SCREEN TEST SYSTEM
- K Number
- K831358
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5090
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Zeus Scientific, Inc.
- Date Received
- April 26, 1983
- Decision Date
- June 15, 1983
- Product Code
- DBM
- Advisory Committee
- Immunology
- Review Advisory Committee
- MI
- 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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