FDA 510(k)

Ensol EnTM Specimen Collection and Transport System

K-번호: K220908 · 2024-08-29

결정일2024-08-29

제품 코드JSM

자문 위원회MI

결정Substantially Equivalent

기기 요약

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

자주 묻는 질문

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. The listed applicant is Ensol Biosciences, Inc.. The 510(k) number is K220908.

When did Ensol EnTM Specimen Collection and Transport System receive FDA 510(k) clearance?

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

Who is the listed applicant for Ensol EnTM Specimen Collection and Transport System?

The FDA 510(k) record lists Ensol Biosciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Ensol EnTM Specimen Collection and Transport System

기기 요약

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관련 임상시험

관련 기기 (코드: JSM)

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