FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANTI-MUTATED CITRULLINATED VIMENTIN EIA
K Number: K092399
·
Decision Jul 1, 2010
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
3
Review Days
329
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Basic Information
- Device Name
- ANTI-MUTATED CITRULLINATED VIMENTIN EIA
- K Number
- K092399
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orgentec Diagnostika GmbH
- Date Received
- August 6, 2009
- Decision Date
- July 1, 2010
- Product Code
- OQZ
- 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 |
|---|---|---|---|
| OQZ | Anti-Mutated Citrullinated Vimentin Igg | FDA class 2 | Immunology |