KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit— 510(k) K171731

Name: FDA 510(k) clearance K171731
Creator: U.S. Food and Drug Administration
Published: 2018-01-19

Substantially Equivalent

Kronus, Inc.

FDA 510(k) clearance K171731 for KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit, Substantially Equivalent on 2018-01-19. Applicant: Kronus, Inc.. Device class: 2.

Clearance details

Applicant: Kronus, Inc.
Product code: Code OIF
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2017-06-12
Decision date: 2018-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Star, ID, US

Download summary PDF View on FDA.gov ↗

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