FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
K Number: K992041
·
Decision Jul 23, 1999
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
111
Applicant Total
36
Review Days
36
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
- RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
- K Number
- K992041
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immuno Concepts, Inc.
- Date Received
- June 17, 1999
- Decision Date
- July 23, 1999
- Product Code
- LJM
- 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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJM), ordered by most recent decision date.
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
ImmuLisa Enhanced Centromere Antibody ELISA
FDA 510(k)
FDA Class 2
·Immunology
ELIA SCL-70S IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
QUANTA FLASH CENTROMERE
FDA 510(k)
FDA Class 2
·Immunology
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
ANA SCREEN ELISA (IGG)
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Immuno Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013432 | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G | Nov 29, 2001 | Substantially Equivalent |
| K013285 | RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 | Nov 14, 2001 | Substantially Equivalent |
| K013283 | RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 | Nov 14, 2001 | Substantially Equivalent |
| K983924 | HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO | Dec 18, 1998 | Substantially Equivalent |
| K972145 | HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM | Feb 24, 1998 | Substantially Equivalent |
| K974478 | IMMUNO CONCEPTS ANCA TEST SYSTEMS | Feb 9, 1998 | Substantially Equivalent |
| K974463 | IMMUNO CONCEPTS ANCA TEST SYSTEM | Feb 9, 1998 | Substantially Equivalent |
| K963275 | RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM | Sep 13, 1996 | Substantially Equivalent |
| K955605 | RELISA JO-1 ANTIBODY TEST SYSTEM | Apr 19, 1996 | Substantially Equivalent |
| K955604 | RELISA SM/RNP ANTIBODY TEST SYSTEM | Apr 19, 1996 | Substantially Equivalent |