FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K Number: K972145
·
Decision Feb 24, 1998
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
109
Applicant Total
36
Review Days
263
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Basic Information
- Device Name
- HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
- K Number
- K972145
- 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 6, 1997
- Decision Date
- February 24, 1998
- Product Code
- DHN
- 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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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 |
| K992041 | RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 | Jul 23, 1999 | Substantially Equivalent |
| K983924 | HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO | Dec 18, 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 |