EUROIMMUN Anti-West Nile Virus ELISA (IgM)— 510(k) K153308
Substantially EquivalentEuroimmun Us, Inc.
FDA 510(k) clearance K153308 for EUROIMMUN Anti-West Nile Virus ELISA (IgM), Substantially Equivalent on 2016-08-12. Applicant: Euroimmun Us, Inc.. Device class: 2.
Clearance details
- Applicant
- Euroimmun Us, Inc.
- Product code
- Code NOP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3940
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morris Plains, NJ, US
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