FDA 510(k)

Familia ACL TOP 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)

N.º K: K242127 · 2024-08-16

SolicitanteInstrumentation Laboratory (IL) Co.

Fecha de decisión2024-08-16

Código de productoGKP

Comité asesorHE

DecisiónSubstantially Equivalent

Resumen del dispositivo

ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory (IL) Co.. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K242127. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)?

ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is Instrumentation Laboratory (IL) Co.. The 510(k) number is K242127.

When did ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) receive FDA 510(k) clearance?

ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) received FDA 510(k) clearance on 2024-08-16, under 510(k) number K242127.

Who is the listed applicant for ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)?

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

What is the FDA product code for ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)?

The FDA product code for ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) is GKP.

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Otros registros que enlistan a Instrumentation Laboratory (IL) Co. como solicitante

K260551HemosIL Factor V Leiden (APC Resistance V)K253957HemosIL Silica Clotting Time K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL K243374HemosIL CL HIT-IgG(PF4-H)

Dispositivos relacionados (Código: GKP)

K231031Familia ACL TOP 70 SeriesInstrumentation Laboratory Company K160276ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)Instrumentation Laboratory CO

Fuente oficial

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