FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM
K Number: K914550
·
Decision Feb 11, 1992
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
49
Applicant Total
4
Review Days
123
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Basic Information
- Device Name
- ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM
- K Number
- K914550
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Resources, Inc.
- Date Received
- October 11, 1991
- Decision Date
- February 11, 1992
- Product Code
- LKJ
- 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 |
|---|---|---|---|
| LKJ | Antinuclear Antibody, Antigen, Control | FDA class 2 | Immunology |
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