FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
K Number: K183313
·
Decision Feb 28, 2019
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
39
Applicant Total
19
Review Days
91
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Basic Information
- Device Name
- EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
- K Number
- K183313
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Euroimmun Us, Inc.
- Date Received
- November 29, 2018
- Decision Date
- February 28, 2019
- Product Code
- MVM
- 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 |
|---|---|---|---|
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | FDA class 2 | Immunology |
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Other Clearances by Euroimmun Us, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG) | Sep 17, 2020 | Substantially Equivalent |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern | May 24, 2018 | Substantially Equivalent |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | Apr 20, 2018 | Substantially Equivalent |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | Apr 20, 2018 | Substantially Equivalent |
| 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 |
| K100017 | EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM | Sep 13, 2010 | Substantially Equivalent |