FDA 510(k)

BD BACTEC™ Myco/F Lytic Culture Vials

N.º K: K222559 · 2023-03-24

SolicitanteBecton, Dickinson and Company

Fecha de decisión2023-03-24

Código de productoMDB

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

BD BACTEC™ Myco/F Lytic Culture Vials is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K222559. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BD BACTEC™ Myco/F Lytic Culture Vials?

BD BACTEC™ Myco/F Lytic Culture Vials is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K222559.

When did BD BACTEC™ Myco/F Lytic Culture Vials receive FDA 510(k) clearance?

BD BACTEC™ Myco/F Lytic Culture Vials received FDA 510(k) clearance on 2023-03-24, under 510(k) number K222559.

Who is the listed applicant for BD BACTEC™ Myco/F Lytic Culture Vials?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD BACTEC™ Myco/F Lytic Culture Vials?

The FDA product code for BD BACTEC™ Myco/F Lytic Culture Vials is MDB.

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 Becton, Dickinson and Company como solicitante

K262163BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth K260128BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube K260184Onclarity™ Self-Collection Kit K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

Ver todos los 102 dispositivos →

Dispositivos relacionados (Código: MDB)

K260213BD BACTEC FXI Culture SystemBD Diagnostic Systems K222591BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson and Company K190405BACT/ALERT MP Reagent SystembioMerieux, Inc.K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc.K173873BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic VialBecton, Dickinson and Company K161816BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUObioMerieux, 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.