FDA 510(k)

ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)

N.º K: K161495 · 2016-06-30

Fecha de decisión2016-06-30

Código de productoOOI

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K161495. The device is classified under product code OOI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)?

ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Luminex Corporation. The 510(k) number is K161495.

When did ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) receive FDA 510(k) clearance?

ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) received FDA 510(k) clearance on 2016-06-30, under 510(k) number K161495.

Who is the listed applicant for ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)?

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

What is the FDA product code for ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)?

The FDA product code for ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) is OOI.

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 Luminex Corporation como solicitante

K253722LIAISON PLEX Gastrointestinal Flex Assay K243490LIAISON PLEX Gram-Positive Blood Culture Assay K243013LIAISON PLEX Gram-Negative Blood Culture Assay K240627LIAISON PLEX Yeast Blood Culture Assay K233410LIAISON PLEX Respiratory Flex Assay K191742ARIES MRSA Assay

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: OOI)

K243922RevogeneMeridian Bioscience, Inc.K222779RevogeneMeridian Bioscience, Inc.K220480RevogeneMeridian Bioscience, Inc.K170558revogeneGenepoc, Inc.K160517ARIES SystemLuminex Corporation

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.