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FDA 510(k)

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite

K-Number: K150597 · 2016-02-29

ApplicantPhadia AB
Decision Date2016-02-29
Product CodeDHB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2016-02-29 under approval number K150597. 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 ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite?

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite is a medical device that received FDA 510(k) clearance on 2016-02-29. It is manufactured by Phadia AB. The 510(k) number is K150597.

When was ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite approved by the FDA?

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite received FDA 510(k) clearance on 2016-02-29, under approval number K150597.

What company makes ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite?

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite is manufactured by Phadia AB.

What is the FDA product code for ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite?

The FDA product code for ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite is DHB.

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Related Devices (Code: DHB)

K151029Phadia PrimePhadia AB K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgEPhadia AB K182479NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinusHycor Biomedical K173726ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, PeanutPhadia AB K191510Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinaeHycor Biomedical K190315ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 CatPhadia AB

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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