EUROIMMUN LYME ELISA(IgG/IgM)
FDA 510(k) clearance K142038 · decided 2015-05-04
Clearance details
- K-number
- K142038
- Device name
- EUROIMMUN LYME ELISA(IgG/IgM)
- Applicant
- Euroimmun US
- Decision
- Substantially Equivalent
- Date received
- 2014-07-28
- Decision date
- 2015-05-04
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- LSR
- Device class
- 2
- Regulation number
- 866.3830
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Morris Plains, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.