FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT
K Number: K971464
·
Decision Oct 29, 1997
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
23
Applicant Total
6
Review Days
190
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Basic Information
- Device Name
- IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT
- K Number
- K971464
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Euro-Diagnostica AB
- Date Received
- April 22, 1997
- Decision Date
- October 29, 1997
- Product Code
- DBL
- 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 |
|---|---|---|---|
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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Other Clearances by Euro-Diagnostica AB
| K Number | Device Name | ||
|---|---|---|---|
| K093908 | CCPOINT | Dec 1, 2010 | Substantially Equivalent |
| K091657 | IMMUNOSCAN CCPLUS | Nov 19, 2009 | Substantially Equivalent |
| K062045 | EDIA ANTI-CCP | Dec 4, 2006 | Substantially Equivalent |
| K971690 | IMMUNOSCAN PR3-ANCA | Oct 29, 1997 | Substantially Equivalent |
| K971689 | IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT | Oct 29, 1997 | Substantially Equivalent |