Quantia IgE
K-Number: K214068 · 2023-02-21
ApplicantBiokit, S.A.
Decision Date2023-02-21
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Quantia IgE is a medical device manufactured by Biokit, S.A.. It received FDA 510(k) clearance on 2023-02-21 under approval number K214068. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Quantia IgE?
Quantia IgE is a medical device that received FDA 510(k) clearance on 2023-02-21. It is manufactured by Biokit, S.A.. The 510(k) number is K214068.
When was Quantia IgE approved by the FDA?
Quantia IgE received FDA 510(k) clearance on 2023-02-21, under approval number K214068.
What company makes Quantia IgE?
Quantia IgE is manufactured by Biokit, S.A..
What is the FDA product code for Quantia IgE?
The FDA product code for Quantia IgE is DGC.
Other Devices by Biokit, S.A.
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K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.
K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.
K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.
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.