FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NCS RA LATEX TEST
K Number: K841146
·
Decision Apr 20, 1984
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
143
Applicant Total
15
Review Days
35
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
- NCS RA LATEX TEST
- K Number
- K841146
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Ncs Diagnostics, Inc.
- Date Received
- March 16, 1984
- Decision Date
- April 20, 1984
- 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 Ncs Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943498 | KULTSURE STARSWAB (M210), MODIFICATION | Nov 30, 1994 | Substantially Equivalent |
| K943499 | KULTSURE STARSWAB(M240), MODIFICATION | Nov 30, 1994 | Substantially Equivalent |
| K882811 | STREPSLIDE | Oct 25, 1988 | Substantially Equivalent |
| K881209 | ASO SLIDE TEST | Apr 12, 1988 | Substantially Equivalent |
| K874019 | STAPHSLIDE | Oct 28, 1987 | Substantially Equivalent |
| K871404 | KULTSURE | Apr 21, 1987 | Substantially Equivalent |
| K870231 | KULTSURE | Feb 4, 1987 | Substantially Equivalent |
| K860178 | KULTSURE (CULTURE TRANSPORT) | Apr 4, 1986 | Substantially Equivalent |
| K860655 | KULTSURE (CATALOGUE NO. M200) | Mar 6, 1986 | Substantially Equivalent |
| K860657 | KULTSURE (CATALOGUE NO. M240) | Mar 4, 1986 | Substantially Equivalent |