FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
K Number: K970198
·
Decision Feb 20, 1997
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
14
Review Days
30
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Basic Information
- Device Name
- IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
- K Number
- K970198
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Scimedx Corp.
- Date Received
- January 21, 1997
- Decision Date
- February 20, 1997
- Product Code
- DHN
- 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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| K002189 | GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM | Oct 19, 2000 | Substantially Equivalent |
| K002169 | GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM | Oct 19, 2000 | Substantially Equivalent |
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| K994379 | EU-TTG IGA ELISA | Feb 18, 2000 | Substantially Equivalent |
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