FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERO/TEX RED CELL RF TEST
K Number: K831597
·
Decision Jun 30, 1983
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
143
Applicant Total
27
Review Days
44
Basic Information
- Device Name
- SERO/TEX RED CELL RF TEST
- K Number
- K831597
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- TEXAS IMMUNOLOGY, INC.
- Date Received
- May 17, 1983
- Decision Date
- June 30, 1983
- 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 TEXAS IMMUNOLOGY, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K991465 | DRUG STOP | Dec 10, 1999 | Substantially Equivalent |
| K980153 | DRUG CHECK | Mar 27, 1998 | Substantially Equivalent |
| K973208 | FIRST SIGN | Oct 20, 1997 | Substantially Equivalent |
| K972094 | TARGET CARDIAC TROPONIN I TEST | Jul 23, 1997 | Substantially Equivalent |
| K963680 | TARGET MYOGLOBIN TEST | Feb 6, 1997 | Substantially Equivalent |
| K912246 | TARGET MICROALBUMINURIA TEST | Jul 19, 1991 | Substantially Equivalent |
| K910073 | TARGET ASO TEST | May 21, 1991 | Substantially Equivalent |
| K904105 | V-TREND TARGET RF TEST | Oct 15, 1990 | Substantially Equivalent |
| K892231 | V-TREND TARGET CRP TEST | Apr 21, 1989 | Substantially Equivalent |
| K890423 | V-TREND TARGET CRP TEST | Feb 17, 1989 | Substantially Equivalent |