FDA 510(k)

ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)

Número K: K160276 · 2016-03-03

Data da decisão2016-03-03

Código do produtoGKP

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2016-03-03 under 510(k) number K160276. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)?

ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K160276.

When did ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) receive FDA 510(k) clearance?

ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) received FDA 510(k) clearance on 2016-03-03, under 510(k) number K160276.

Who is the listed applicant for ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)?

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

What is the FDA product code for ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)?

The FDA product code for ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) is GKP.

Outros registros que listam Instrumentation Laboratory CO como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipina IgM, HemosIL CL Anti-ß2 Glicoproteína-I IgM K223187HemosIL Liquid Anti-Xa K223090GEM Premier ChemSTAT K223402HemosIL von Willebrand Factor Antigen K213464HemosIL Liquid Anti-Xa K213426HemosIL ReadiPlasTin

Ver todos os 25 dispositivos →

Dispositivos Relacionados (Código: GKP)

K242127Família ACL TOP 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)Instrumentation Laboratory (IL) Co.K231031Família ACL TOP 70 SeriesInstrumentation Laboratory Company

Fonte oficial

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