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FDA 510(k)

Phadia Prime

K-Number: K151029 · 2016-01-19

ApplicantPhadia AB
Decision Date2016-01-19
Product CodeDHB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Phadia Prime is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2016-01-19 under approval number K151029. 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 Phadia Prime?

Phadia Prime is a medical device that received FDA 510(k) clearance on 2016-01-19. It is manufactured by Phadia AB. The 510(k) number is K151029.

When was Phadia Prime approved by the FDA?

Phadia Prime received FDA 510(k) clearance on 2016-01-19, under approval number K151029.

What company makes Phadia Prime?

Phadia Prime is manufactured by Phadia AB.

What is the FDA product code for Phadia Prime?

The FDA product code for Phadia Prime is DHB.

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 K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE K183007EliA SmDP Immunoassay K182747EliA RF IgM Immunoassay

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Related Devices (Code: DHB)

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