KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay— 510(k) K161951

Substantially Equivalent

Kronus, Inc.

FDA 510(k) clearance K161951 for KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay, Substantially Equivalent on 2016-07-22. Applicant: Kronus, Inc..

Clearance details

Applicant: Kronus, Inc.
Product code: Code PNI
Advisory panel: Immunology
Date received: 2016-07-15
Decision date: 2016-07-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Star, ID, US

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