Anti-Borrelia burgdorferi US Westernblot (IgG)— 510(k) K161513
Substantially EquivalentEuroimmun US
FDA 510(k) clearance K161513 for Anti-Borrelia burgdorferi US Westernblot (IgG), Substantially Equivalent on 2016-08-25. Applicant: Euroimmun US. Device class: 2.
Clearance details
- Applicant
- Euroimmun US
- Product code
- Code LSR
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morris Plains, NJ, US
Recent devices under product code LSR
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