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FDA 510(k)

Omni Instrument Tray

K-Number: K182052 · 2019-02-26

ApplicantHologic, Inc.
Decision Date2019-02-26
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Omni Instrument Tray is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2019-02-26 under approval number K182052. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omni Instrument Tray?

Omni Instrument Tray is a medical device that received FDA 510(k) clearance on 2019-02-26. It is manufactured by Hologic, Inc.. The 510(k) number is K182052.

When was Omni Instrument Tray approved by the FDA?

Omni Instrument Tray received FDA 510(k) clearance on 2019-02-26, under approval number K182052.

What company makes Omni Instrument Tray?

Omni Instrument Tray is manufactured by Hologic, Inc..

What is the FDA product code for Omni Instrument Tray?

The FDA product code for Omni Instrument Tray is KCT.

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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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