EUROIMMUN ANTI-NRNP/SM ELISA (IGG)— 510(k) K123261
Substantially EquivalentEuroimmun US
FDA 510(k) clearance K123261 for EUROIMMUN ANTI-NRNP/SM ELISA (IGG), Substantially Equivalent on 2013-06-12. Applicant: Euroimmun US. Device class: 2.
Clearance details
- Applicant
- Euroimmun US
- Product code
- Code LKO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morris Plains, NJ, US
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More clearances from Euroimmun US
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