FDA 510(k)

ARCHITECT淋病TP试剂, ARCHITECT淋病TP 캘리브레이터, ARCHITECT淋病TP 컨트롤

K-번호: K153730 · 2016-06-15

결정일2016-06-15

제품 코드LIP

자문 위원회MI

결정Substantially Equivalent

기기 요약

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2016-06-15 under 510(k) number K153730. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control?

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control is a medical device that received FDA 510(k) clearance on 2016-06-15. The listed applicant is Abbott Laboratories. The 510(k) number is K153730.

When did ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control receive FDA 510(k) clearance?

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control received FDA 510(k) clearance on 2016-06-15, under 510(k) number K153730.

Who is the listed applicant for ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control?

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

What is the FDA product code for ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control?

The FDA product code for ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control is LIP.

Abbott Laboratories를 신청인으로 등재한 기타 기록

K262156Anti-HCV Next K252424Anti-HCV Next K243500ARCHITECT 이젠티미신 K243168Alinity i 루브렐라 IgG K243283Alinity h-series 시스템 K233932Alinity i 토크소 IgM

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