FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RA-CHECK
K Number: K831467
·
Decision Jun 8, 1983
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
143
Applicant Total
28
Review Days
33
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-CHECK
- K Number
- K831467
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Technology, Inc.
- Date Received
- May 6, 1983
- Decision Date
- June 8, 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 Diagnostic Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896378 | LYME-CHECK(TM) TEST KIT | Nov 5, 1991 | Substantially Equivalent |
| K903612 | EBV/EA-CHECK TM TEST KIT | Oct 16, 1990 | Substantially Equivalent |
| K890639 | RESUBMITTED EBV/IGM-CHECK TEST KIT | Jun 20, 1989 | Substantially Equivalent |
| K891542 | EBNA-CHECK(TM) TEST KIT | Jun 20, 1989 | Substantially Equivalent |
| K890819 | HSV-CHECK(TM) TEST KIT | Jun 20, 1989 | Substantially Equivalent |
| K871373 | EBV-CHECK(TM) TEST KIT (IGG) | Jun 25, 1987 | Substantially Equivalent |
| K864128 | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT | Apr 29, 1987 | Substantially Equivalent |
| K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | Nov 28, 1986 | Substantially Equivalent |
| K860586 | PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS | May 7, 1986 | Substantially Equivalent |
| K860166 | PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 | Apr 4, 1986 | Substantially Equivalent |