FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EUROIMMUN ANTI-M2-3E ELISA (IGG)
K Number: K092736
·
Decision Sep 2, 2010
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
26
Applicant Total
19
Review Days
363
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Basic Information
- Device Name
- EUROIMMUN ANTI-M2-3E ELISA (IGG)
- K Number
- K092736
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5090
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Euroimmun Us, Inc.
- Date Received
- September 4, 2009
- Decision Date
- September 2, 2010
- Product Code
- DBM
- 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 |
|---|---|---|---|
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | Dec 10, 2017 | Substantially Equivalent |
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | Aug 12, 2016 | Substantially Equivalent |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | Aug 10, 2016 | Substantially Equivalent |
| K141827 | EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE | Apr 17, 2015 | Substantially Equivalent |
| K132195 | EUROIMMUN ANTI-PLA2R ELISA (IGG) | Jun 27, 2014 | Substantially Equivalent |