FDA 510(k)

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

N.º K: K202574 · 2021-02-18

Fecha de decisión2021-02-18

Código de productoLSR

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2021-02-18 under 510(k) number K202574. 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 IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus?

LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus is a medical device that received FDA 510(k) clearance on 2021-02-18. The listed applicant is DiaSorin, Inc.. The 510(k) number is K202574.

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

LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus received FDA 510(k) clearance on 2021-02-18, under 510(k) number K202574.

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

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

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

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

Ver todos los 25 dispositivos →

Dispositivos relacionados (Código: LSR)

K254295Sofia Lyme FIA; Sofia 2 Campylobacter FIAOrtho-Clinical Diagnostics, Inc. (QuidelOrtho)K252627Lyme-ID IgG Test; Bio-ID800Inanovate, Inc.K242872Kit de IgM ImmunoBlot para Lyme iDartId-Fish Technology, Inc.K233367iDart Lyme IgG ImmunoBlot KitId-Fish Technology, Inc.K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitZeus Scientific K220016Viramed Borrela All-In-One ViraChip Test KitViramed Biotech AG

Fuente oficial

Ver en la base de datos de la FDA →

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