ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE
K-Number: K163370 · 2017-05-05
ApplicantPhadia AB
Decision Date2017-05-05
Product CodeDHB
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2017-05-05 under approval number K163370. 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 w1, Common ragweed; ImmunoCAP Specific IgE?
ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE is a medical device that received FDA 510(k) clearance on 2017-05-05. It is manufactured by Phadia AB. The 510(k) number is K163370.
When was ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE approved by the FDA?
ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE received FDA 510(k) clearance on 2017-05-05, under approval number K163370.
What company makes ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE?
ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE is manufactured by Phadia AB.
What is the FDA product code for ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE?
The FDA product code for ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE 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.