K182479

Substantially Equivalent

NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus

Applicant: Hycor Biomedical
Product code: DHB
Advisory panel: Immunology
Date received: 2018-09-10
Decision date: 2018-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

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