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FDA 510(k)

REMI-AI Rapid Detection Module (REMI-AI RDM)

K-Number: K240408 · 2024-10-17

ApplicantEpitel, Inc.
Decision Date2024-10-17
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REMI-AI Rapid Detection Module (REMI-AI RDM) is a medical device manufactured by Epitel, Inc.. It received FDA 510(k) clearance on 2024-10-17 under approval number K240408. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMI-AI Rapid Detection Module (REMI-AI RDM)?

REMI-AI Rapid Detection Module (REMI-AI RDM) is a medical device that received FDA 510(k) clearance on 2024-10-17. It is manufactured by Epitel, Inc.. The 510(k) number is K240408.

When was REMI-AI Rapid Detection Module (REMI-AI RDM) approved by the FDA?

REMI-AI Rapid Detection Module (REMI-AI RDM) received FDA 510(k) clearance on 2024-10-17, under approval number K240408.

What company makes REMI-AI Rapid Detection Module (REMI-AI RDM)?

REMI-AI Rapid Detection Module (REMI-AI RDM) is manufactured by Epitel, Inc..

What is the FDA product code for REMI-AI Rapid Detection Module (REMI-AI RDM)?

The FDA product code for REMI-AI Rapid Detection Module (REMI-AI RDM) is OMB.

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Related PubMed Literature

PMID: 40801347 Loop-mediated isothermal amplification (LAMP)-based microbial detection: a review of FDA-authorized tests and future perspectives. Critical reviews in clinical laboratory sciences (2026)

Other Devices by Epitel, Inc.

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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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