FDA 510(k)

Alere i RSV, Alere i 도구, Alere i RSV 컨트롤 스웨브 키트

K-번호: K161375 · 2016-08-18

결정일2016-08-18

제품 코드OCC

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit is the device name listed in this FDA 510(k) record. The listed applicant is Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K161375. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit?

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K161375.

When did Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit receive FDA 510(k) clearance?

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit received FDA 510(k) clearance on 2016-08-18, under 510(k) number K161375.

Who is the listed applicant for Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit?

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

What is the FDA product code for Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit?

The FDA product code for Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit is OCC.

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