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FDA 510(k)

Allergen-Specific IgE Assay 12 Allergen Bundle

K-Number: K193613 · 2021-10-18

ApplicantHitachi Chemical Diagnostics, Inc.
Decision Date2021-10-18
Product CodeDHB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Allergen-Specific IgE Assay 12 Allergen Bundle is a medical device manufactured by Hitachi Chemical Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-10-18 under approval number K193613. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Allergen-Specific IgE Assay 12 Allergen Bundle?

Allergen-Specific IgE Assay 12 Allergen Bundle is a medical device that received FDA 510(k) clearance on 2021-10-18. It is manufactured by Hitachi Chemical Diagnostics, Inc.. The 510(k) number is K193613.

When was Allergen-Specific IgE Assay 12 Allergen Bundle approved by the FDA?

Allergen-Specific IgE Assay 12 Allergen Bundle received FDA 510(k) clearance on 2021-10-18, under approval number K193613.

What company makes Allergen-Specific IgE Assay 12 Allergen Bundle?

Allergen-Specific IgE Assay 12 Allergen Bundle is manufactured by Hitachi Chemical Diagnostics, Inc..

What is the FDA product code for Allergen-Specific IgE Assay 12 Allergen Bundle?

The FDA product code for Allergen-Specific IgE Assay 12 Allergen Bundle is DHB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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