EUROIMMUN ANTI-M2-3E ELISA (IGG)— 510(k) K092736
Substantially EquivalentEuroimmun Us, Inc.
FDA 510(k) clearance K092736 for EUROIMMUN ANTI-M2-3E ELISA (IGG), Substantially Equivalent on 2010-09-02. Applicant: Euroimmun Us, Inc.. Device class: 2.
Clearance details
- Applicant
- Euroimmun Us, Inc.
- Product code
- Code DBM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5090
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morristown, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.