FDA 510(k)

ASI 자동 ASI RPR 테스트 for 소양증 on the ASI Evolution

K-번호: K182391 · 2018-11-30

결정일2018-11-30

제품 코드GMQ

자문 위원회미 (Original text: MI)

결정Substantially Equivalent

기기 요약

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution is the device name listed in this FDA 510(k) record. The listed applicant is Arlington Scientific, Inc. (Asi). It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K182391. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ASI Automated ASI RPR Test for Syphilis on the ASI Evolution?

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Arlington Scientific, Inc. (Asi). The 510(k) number is K182391.

When did ASI Automated ASI RPR Test for Syphilis on the ASI Evolution receive FDA 510(k) clearance?

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution received FDA 510(k) clearance on 2018-11-30, under 510(k) number K182391.

Who is the listed applicant for ASI Automated ASI RPR Test for Syphilis on the ASI Evolution?

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

What is the FDA product code for ASI Automated ASI RPR Test for Syphilis on the ASI Evolution?

The FDA product code for ASI Automated ASI RPR Test for Syphilis on the ASI Evolution is GMQ.

Arlington Scientific, Inc. (Asi)를 신청인으로 등재한 기타 기록

K201438ASI 자동 RPR (빠른 혈액 반응 테스트) 테스트 for 소양증, ASI Evolution 자동 소양증 분석기 사용 K173376ASI Evolution

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