FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REUMA TEST
K Number: K873782
·
Decision Nov 27, 1987
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
143
Applicant Total
82
Review Days
72
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
- REUMA TEST
- K Number
- K873782
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Sclavo, Inc.
- Date Received
- September 16, 1987
- Decision Date
- November 27, 1987
- 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
Other Clearances by Sclavo, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914789 | ELISA CMV IGM | Mar 4, 1992 | Substantially Equivalent |
| K914852 | ELISA TOXO IGM | Jan 23, 1992 | Substantially Equivalent |
| K914420 | ELISA RUBELLA IGM | Dec 27, 1991 | Substantially Equivalent |
| K895943 | NORMAL AND ABNORMAL CONTROL SERA | Dec 27, 1989 | Substantially Equivalent |
| K895822 | TOTAL BILIRUBIN L.F. | Nov 14, 1989 | Substantially Equivalent |
| K895847 | CREATININE 340 (ENZYMATIC) | Oct 30, 1989 | Substantially Equivalent |
| K880049 | CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE | Jan 27, 1989 | Substantially Equivalent |
| K880199 | CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE | Jan 27, 1989 | Substantially Equivalent |
| K873496 | ATYPICAL CHOLINESTERASE | Jan 27, 1989 | Substantially Equivalent |
| K884035 | SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER | Dec 29, 1988 | Substantially Equivalent |