FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNOSCAN PR3-ANCA
K Number: K971690
·
Decision Oct 29, 1997
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
73
Applicant Total
6
Review Days
175
Basic Information
- Device Name
- IMMUNOSCAN PR3-ANCA
- K Number
- K971690
- 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
- May 7, 1997
- Decision Date
- October 29, 1997
- Product Code
- MOB
- 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 |
|---|---|---|---|
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 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 |
| K971689 | IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT | Oct 29, 1997 | Substantially Equivalent |
| K971464 | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT | Oct 29, 1997 | Substantially Equivalent |