FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEALTHTEST RHEUMATOID FACTOR ASSAY
K Number: K920220
·
Decision Mar 13, 1992
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
143
Applicant Total
3
Review Days
57
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Basic Information
- Device Name
- HEALTHTEST RHEUMATOID FACTOR ASSAY
- K Number
- K920220
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Akers Research Corp.
- Date Received
- January 16, 1992
- Decision Date
- March 13, 1992
- Product Code
- DHR
- 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 |
|---|---|---|---|
| DHR | System, Test, Rheumatoid Factor | FDA class 2 | Immunology |
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