FDA 510(k)

BioSci™ 사용 가능한 바이러스 샘플링 튜브

K-번호: K230035 · 2023-04-05

신청자Shenzhen Dakewe Bio-Engineering Co., Ltd.

결정일2023-04-05

제품 코드JSM

자문 위원회미 (Original text: MI)

결정Substantially Equivalent

기기 요약

BioSci™ Disposable Virus Sampling Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dakewe Bio-Engineering Co., Ltd.. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K230035. 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 BioSci™ Disposable Virus Sampling Tubes?

BioSci™ Disposable Virus Sampling Tubes is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Shenzhen Dakewe Bio-Engineering Co., Ltd.. The 510(k) number is K230035.

When did BioSci™ Disposable Virus Sampling Tubes receive FDA 510(k) clearance?

BioSci™ Disposable Virus Sampling Tubes received FDA 510(k) clearance on 2023-04-05, under 510(k) number K230035.

Who is the listed applicant for BioSci™ Disposable Virus Sampling Tubes?

The FDA 510(k) record lists Shenzhen Dakewe Bio-Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioSci™ Disposable Virus Sampling Tubes?

The FDA product code for BioSci™ Disposable Virus Sampling Tubes is JSM.

Shenzhen Dakewe Bio-Engineering Co., Ltd.를 신청인으로 등재한 기타 기록

K240235OmniTrans Transport System K220059바이오사이™ 비활성화된 운반 미디어, 바이오사이™ ITM

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