510(k) K193613— Allergen-Specific IgE Assay 12 Allergen Bundle

Substantially Equivalent

Hitachi Chemical Diagnostics, Inc.

Clearance details

Applicant: Hitachi Chemical Diagnostics, Inc.
Product code: Code DHB
Advisory panel: Immunology
Date received: 2019-12-26
Decision date: 2021-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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