FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
K Number: K993304
·
Decision Dec 6, 1999
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
143
Applicant Total
31
Review Days
63
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Basic Information
- Device Name
- AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
- K Number
- K993304
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cogent Diagnotics , Ltd.
- Date Received
- October 4, 1999
- Decision Date
- December 6, 1999
- Product Code
- DHR
- 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 |
|---|---|---|---|
| DHR | System, Test, Rheumatoid Factor | FDA class 2 | Immunology |
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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 |
| K002215 | AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA | Sep 28, 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 |
| 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 |