FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RA-80 POSITIVE CONTROL
K Number: K813309
·
Decision Dec 17, 1981
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
143
Applicant Total
1
Review Days
23
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RA-80 POSITIVE CONTROL
- K Number
- K813309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Sun-Kit
- Date Received
- November 24, 1981
- Decision Date
- December 17, 1981
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DHR), ordered by most recent decision date.
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
FDA 510(k)
FDA Class 2
·Immunology
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
FDA 510(k)
FDA Class 2
·Immunology
EliA RF IgM Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
Optilite Rheumatoid Factor Kit
FDA 510(k)
FDA Class 2
·Immunology
Rheumatoid Factor (RF) Kit for use on SPAPLUS
FDA 510(k)
FDA Class 2
·Immunology
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
FDA 510(k)
FDA Class 2
·Immunology