FDA 510(k)

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K-번호: K153128 · 2017-01-13

결정일2017-01-13

제품 코드HHT

자문 위원회OB

결정Substantially Equivalent

기기 요약

Kolplast Cervical Sample Collection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Kolplast CI SA. It received FDA 510(k) clearance on 2017-01-13 under 510(k) number K153128. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Kolplast Cervical Sample Collection Kit?

Kolplast Cervical Sample Collection Kit is a medical device that received FDA 510(k) clearance on 2017-01-13. The listed applicant is Kolplast CI SA. The 510(k) number is K153128.

When did Kolplast Cervical Sample Collection Kit receive FDA 510(k) clearance?

Kolplast Cervical Sample Collection Kit received FDA 510(k) clearance on 2017-01-13, under 510(k) number K153128.

Who is the listed applicant for Kolplast Cervical Sample Collection Kit?

The FDA 510(k) record lists Kolplast CI SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kolplast Cervical Sample Collection Kit?

The FDA product code for Kolplast Cervical Sample Collection Kit is HHT.

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관련 임상시험

관련 기기 (코드: HHT)

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