FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
K Number: K083053
·
Decision Aug 7, 2009
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
41
Applicant Total
19
Review Days
297
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Basic Information
- Device Name
- EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
- K Number
- K083053
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5750
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Euroimmun Us, Inc.
- Date Received
- October 14, 2008
- Decision Date
- August 7, 2009
- Product Code
- MST
- 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 |
|---|---|---|---|
| MST | Antibodies, Gliadin | FDA class 2 | Immunology |
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Other Clearances by Euroimmun Us, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern | May 24, 2018 | Substantially Equivalent |
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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 |