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FDA 510(k)

Kenota 1 Total IgE; Kenota 1 (instrument)

K-Number: K231151 · 2024-05-31

ApplicantKenota, Inc.
Decision Date2024-05-31
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Kenota 1 Total IgE; Kenota 1 (instrument) is a medical device manufactured by Kenota, Inc.. It received FDA 510(k) clearance on 2024-05-31 under approval number K231151. 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 Kenota 1 Total IgE; Kenota 1 (instrument)?

Kenota 1 Total IgE; Kenota 1 (instrument) is a medical device that received FDA 510(k) clearance on 2024-05-31. It is manufactured by Kenota, Inc.. The 510(k) number is K231151.

When was Kenota 1 Total IgE; Kenota 1 (instrument) approved by the FDA?

Kenota 1 Total IgE; Kenota 1 (instrument) received FDA 510(k) clearance on 2024-05-31, under approval number K231151.

What company makes Kenota 1 Total IgE; Kenota 1 (instrument)?

Kenota 1 Total IgE; Kenota 1 (instrument) is manufactured by Kenota, Inc..

What is the FDA product code for Kenota 1 Total IgE; Kenota 1 (instrument)?

The FDA product code for Kenota 1 Total IgE; Kenota 1 (instrument) is DGC.

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Related Devices (Code: DGC)

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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.

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