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FDA 510(k)

Ensol EnTM Specimen Collection and Transport System

K-Number: K220908 · 2024-08-29

ApplicantEnsol Biosciences, Inc.
Decision Date2024-08-29
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Ensol EnTM Specimen Collection and Transport System is a medical device manufactured by Ensol Biosciences, Inc.. It received FDA 510(k) clearance on 2024-08-29 under approval number K220908. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ensol EnTM Specimen Collection and Transport System?

Ensol EnTM Specimen Collection and Transport System is a medical device that received FDA 510(k) clearance on 2024-08-29. It is manufactured by Ensol Biosciences, Inc.. The 510(k) number is K220908.

When was Ensol EnTM Specimen Collection and Transport System approved by the FDA?

Ensol EnTM Specimen Collection and Transport System received FDA 510(k) clearance on 2024-08-29, under approval number K220908.

What company makes Ensol EnTM Specimen Collection and Transport System?

Ensol EnTM Specimen Collection and Transport System is manufactured by Ensol Biosciences, Inc..

What is the FDA product code for Ensol EnTM Specimen Collection and Transport System?

The FDA product code for Ensol EnTM Specimen Collection and Transport System is JSM.

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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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