FDA 510(k)

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set

N.º K: K193051 · 2020-01-29

Fecha de decisión2020-01-29

Código de productoLSR

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2020-01-29 under 510(k) number K193051. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set?

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set is a medical device that received FDA 510(k) clearance on 2020-01-29. The listed applicant is DiaSorin, Inc.. The 510(k) number is K193051.

When did LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set receive FDA 510(k) clearance?

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set received FDA 510(k) clearance on 2020-01-29, under 510(k) number K193051.

Who is the listed applicant for LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set?

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

What is the FDA product code for LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set?

The FDA product code for LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set is LSR.

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Otros registros que enlistan a DiaSorin, Inc. como solicitante

K260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX K231214LIAISON VZV IgG HT, LIAISON Control VZV IgG HT K223403LIAISON Anti-HAV; LIAISON XS K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus K213936LIAISON MeMed BV, LIAISON MeMed BV Control Set K193650LIAISON Ferritin

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.