FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
K Number: K002215
·
Decision Sep 28, 2000
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
73
Applicant Total
31
Review Days
66
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
- AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
- K Number
- K002215
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cogent Diagnotics , Ltd.
- Date Received
- July 24, 2000
- Decision Date
- September 28, 2000
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOB), ordered by most recent decision date.
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
FDA 510(k)
FDA Class 2
·Immunology
EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern
FDA 510(k)
FDA Class 2
·Immunology
AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
FDA 510(k)
FDA Class 2
·Immunology
EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
FDA 510(k)
FDA Class 2
·Immunology
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Cogent Diagnotics , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K003054 | AUTOSTAT II ENA-6 PROFILE ELISA | Oct 13, 2000 | Substantially Equivalent |
| K003057 | AUTOSTAT II ENA-4 PROFILE ELISA | Oct 13, 2000 | Substantially Equivalent |
| K993557 | AUTOSTAT II RHEUMATOID FACTOR IGA ELISA | Mar 3, 2000 | Substantially Equivalent |
| K994338 | AUTOSTAT II RHEUMATOID FACTOR IGM ELISA | Feb 3, 2000 | Substantially Equivalent |
| K993085 | AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA | Feb 1, 2000 | Substantially Equivalent |
| K993304 | AUTOSTAT II RHEUMATOID FACTOR IGG ELISA | Dec 6, 1999 | Substantially Equivalent |
| K992449 | AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA | Nov 24, 1999 | Substantially Equivalent |
| K993086 | AUTOSTAT II ANTI-GLIADIN IGA ELISA | Nov 12, 1999 | Substantially Equivalent |
| K993087 | AUTOSTAT II ANTI-GLIADIN IGG ELISA | Nov 12, 1999 | Substantially Equivalent |
| K992440 | AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA | Sep 21, 1999 | Substantially Equivalent |