FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
AUTOSTATTMII ANTI-DSDNA
K Number: K952567
·
Decision Mar 4, 1997
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
28
Applicant Total
31
Review Days
638
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Basic Information
- Device Name
- AUTOSTATTMII ANTI-DSDNA
- K Number
- K952567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cogent Diagnotics , Ltd.
- Date Received
- June 5, 1995
- Decision Date
- March 4, 1997
- Product Code
- LRM
- 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 |
|---|---|---|---|
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRM), ordered by most recent decision date.
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FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
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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 |
| 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 |