FDA 510(k)

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel

N.º K: K181711 · 2018-08-15

Fecha de decisión2018-08-15

Código de productoPMN

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel is the device name listed in this FDA 510(k) record. The listed applicant is Microbiologics, Inc.. It received FDA 510(k) clearance on 2018-08-15 under 510(k) number K181711. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel?

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel is a medical device that received FDA 510(k) clearance on 2018-08-15. The listed applicant is Microbiologics, Inc.. The 510(k) number is K181711.

When did BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel receive FDA 510(k) clearance?

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel received FDA 510(k) clearance on 2018-08-15, under 510(k) number K181711.

Who is the listed applicant for BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel?

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

What is the FDA product code for BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel?

The FDA product code for BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel is PMN.

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 Microbiologics, Inc. como solicitante

K190086Cepheid Xpert Respiratory Control Panel K191168Cepheid Xpert SA Nasal Complete Control Panel K191172Cepheid Xpert MRSA NxG Control Panel K190223Cepheid Xpert CT/NG Control Panel K190463Cepheid Xpert C. difficile/Epi Control Panel K182472Cepheid Xpert GBS LB Control Panel

Ver todos los 8 dispositivos →

Dispositivos relacionados (Código: PMN)

K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLC K260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc.K260041MDx-Chex for BCPStreck, LLC K254166MDx-Chex for BCNStreck K254167MDx-Chex for BCYStreck, LLC K251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc.

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.