FDA 510(k)

Alere BinaxNOW Influenza A & B Tarjeta 2, Alere Reader

N.º K: K181853 · 2018-08-08

Fecha de decisión2018-08-08

Código de productoPSZ

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

Alere BinaxNOW Influenza A & B Card 2, Alere Reader is the device name listed in this FDA 510(k) record. The listed applicant is Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2018-08-08 under 510(k) number K181853. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

Alere BinaxNOW Influenza A & B Card 2, Alere Reader is a medical device that received FDA 510(k) clearance on 2018-08-08. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K181853.

When did Alere BinaxNOW Influenza A & B Card 2, Alere Reader receive FDA 510(k) clearance?

Alere BinaxNOW Influenza A & B Card 2, Alere Reader received FDA 510(k) clearance on 2018-08-08, under 510(k) number K181853.

Who is the listed applicant for Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

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

What is the FDA product code for Alere BinaxNOW Influenza A & B Card 2, Alere Reader?

The FDA product code for Alere BinaxNOW Influenza A & B Card 2, Alere Reader is PSZ.

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 Alere Scarborough, Inc. como solicitante

K190204ID NOW Influenza A & B 2 K173653Alere i Estreptococo A 2, Alere i instrumento, Alere i Estreptococo A 2 Control Swab Kit K173932Alere i Influenza A & B, Alere i Estreptococo A, Alere i RSV, Alere i Influenza A & B 2 K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

Ver todos los 10 dispositivos →

Dispositivos relacionados (Código: PSZ)

K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)K252283Nano-Check Influenza A+B TestNano-Ditech Corporation K250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K241188Prueba de Influenza A&B Acucy® con el Sistema Acucy® 2SEKISUI Diagnostics, LLC K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd

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.