FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
K Number: K912489
·
Decision Jul 24, 1991
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
55
Applicant Total
36
Review Days
50
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Basic Information
- Device Name
- COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
- K Number
- K912489
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Immuno Concepts, Inc.
- Date Received
- June 4, 1991
- Decision Date
- July 24, 1991
- Product Code
- LSE
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LSE | Epstein-Barr Virus, Other | FDA class 1 | Microbiology |
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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 |
| 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 |