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FDA 510(k)

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut

K-Number: K173726 · 2018-04-16

ApplicantPhadia AB
Decision Date2018-04-16
Product CodeDHB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2018-04-16 under approval number K173726. 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 Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut?

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut is a medical device that received FDA 510(k) clearance on 2018-04-16. It is manufactured by Phadia AB. The 510(k) number is K173726.

When was ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut approved by the FDA?

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut received FDA 510(k) clearance on 2018-04-16, under approval number K173726.

What company makes ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut?

ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut is manufactured by Phadia AB.

What is the FDA product code for ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut?

The FDA product code for ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut is DHB.

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Other Devices by Phadia AB

K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 K150597ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite K151029Phadia Prime K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE K183007EliA SmDP Immunoassay

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Related Devices (Code: DHB)

K150597ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mitePhadia AB 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 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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