510(k) K200825— NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense

Substantially Equivalent

Hycor Biomedical

Clearance details

Applicant: Hycor Biomedical
Product code: Code DHB
Advisory panel: Immunology
Date received: 2020-03-30
Decision date: 2020-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.