K-number	K193613
Device name	Allergen-Specific IgE Assay 12 Allergen Bundle
Applicant	Hitachi Chemical Diagnostics, Inc.
Product code	DHB
Device class	Class II
Decision date	Oct 18, 2021
Decision	Substantially Equivalent
Regulation	866.5750

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Source

View the full FDA submission: accessdata.fda.gov

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Allergen-Specific IgE Assay 12 Allergen Bundle

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