FDA 510(k)

바이오텍 스타일러스 디스포제블 바이러스 샘플링 키트

K-번호: K211707 · 2022-05-04

결정일2022-05-04

제품 코드JSM

자문 위원회MI

결정Substantially Equivalent

기기 요약

BioTeke Sterile Disposable Virus Sampling Kit is the device name listed in this FDA 510(k) record. The listed applicant is Bioteke Corporation (Wuxi) Co., Ltd.. It received FDA 510(k) clearance on 2022-05-04 under 510(k) number K211707. 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 BioTeke Sterile Disposable Virus Sampling Kit?

BioTeke Sterile Disposable Virus Sampling Kit is a medical device that received FDA 510(k) clearance on 2022-05-04. The listed applicant is Bioteke Corporation (Wuxi) Co., Ltd.. The 510(k) number is K211707.

When did BioTeke Sterile Disposable Virus Sampling Kit receive FDA 510(k) clearance?

BioTeke Sterile Disposable Virus Sampling Kit received FDA 510(k) clearance on 2022-05-04, under 510(k) number K211707.

Who is the listed applicant for BioTeke Sterile Disposable Virus Sampling Kit?

The FDA 510(k) record lists Bioteke Corporation (Wuxi) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioTeke Sterile Disposable Virus Sampling Kit?

The FDA product code for BioTeke Sterile Disposable Virus Sampling Kit is JSM.

Bioteke Corporation (Wuxi) Co., Ltd.를 신청인으로 등재한 기타 기록

K261409바이오티케® 다중 약물尿液 검사 컵

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