FDA 510(k)

Alere BinaxNOW 인플루엔자 A & B 카드 2, Alere 리더

K-번호: K181853 · 2018-08-08

결정일2018-08-08

제품 코드PSZ

자문 위원회미 (Original text: MI)

결정Substantially Equivalent

기기 요약

Alere BinaxNOW Influenza A & B Card 2, Alere Reader 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 2018-08-08 under 510(k) number K181853. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

Alere BinaxNOW Influenza A & B Card 2, Alere Reader is a medical device that received FDA 510(k) clearance on 2018-08-08. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K181853.

When did Alere BinaxNOW Influenza A & B Card 2, Alere Reader receive FDA 510(k) clearance?

Alere BinaxNOW Influenza A & B Card 2, Alere Reader received FDA 510(k) clearance on 2018-08-08, under 510(k) number K181853.

Who is the listed applicant for Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

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 BinaxNOW Influenza A & B Card 2, Alere Reader?

The FDA product code for Alere BinaxNOW Influenza A & B Card 2, Alere Reader is PSZ.

Alere Scarborough, Inc.를 신청인으로 등재한 기타 기록

10개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.