FDA 510(k)

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K-번호: K212113 · 2022-07-28

결정일2022-07-28

제품 코드QBD

자문 위원회미 (Original text: MI)

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기기 요약

MagXtract Collection Tube is the device name listed in this FDA 510(k) record. The listed applicant is Magbio Genomics, Inc.. It received FDA 510(k) clearance on 2022-07-28 under 510(k) number K212113. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the MagXtract Collection Tube?

MagXtract Collection Tube is a medical device that received FDA 510(k) clearance on 2022-07-28. The listed applicant is Magbio Genomics, Inc.. The 510(k) number is K212113.

When did MagXtract Collection Tube receive FDA 510(k) clearance?

MagXtract Collection Tube received FDA 510(k) clearance on 2022-07-28, under 510(k) number K212113.

Who is the listed applicant for MagXtract Collection Tube?

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

What is the FDA product code for MagXtract Collection Tube?

The FDA product code for MagXtract Collection Tube is QBD.

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관련 임상시험

관련 기기 (코드: QBD)

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