FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EUROIMMUN LYME ELISA(IgG/IgM)
K Number: K142038
·
Decision May 4, 2015
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
12
Review Days
280
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Basic Information
- Device Name
- EUROIMMUN LYME ELISA(IgG/IgM)
- K Number
- K142038
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Euroimmun US
- Date Received
- July 28, 2014
- Decision Date
- May 4, 2015
- Product Code
- LSR
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | FDA class 2 | Microbiology |
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Other Clearances by Euroimmun US
| K Number | Device Name | ||
|---|---|---|---|
| K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG) | Aug 25, 2016 | Substantially Equivalent |
| K140224 | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) | Dec 9, 2014 | Substantially Equivalent |
| DEN140002 | EUROIMMUN ANTI-PLA2R IFA | May 29, 2014 | Unknown |
| K131791 | IFA 40: HEP-20-10 | Feb 26, 2014 | Substantially Equivalent |
| K123660 | 25-OH VITAMIN D ELISA | Jul 17, 2013 | Substantially Equivalent |
| K131185 | ANA SCREEN ELISA (IGG) | Jul 15, 2013 | Substantially Equivalent |
| K123261 | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) | Jun 12, 2013 | Substantially Equivalent |
| K113439 | EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) | Apr 12, 2013 | Substantially Equivalent |
| K112996 | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | Apr 9, 2013 | Substantially Equivalent |
| K112221 | EUROIMMUN ANTI-SLA/LP ELISA(LGG) | Sep 11, 2012 | Substantially Equivalent |