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510(k) K220193

Device
BD MAX Enteric Parasite Panel
Applicant
Becton, Dickinson And Company
510(k) number
K220193
Product code
PCH  
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-19
Date received
2022-01-24
Regulation
866.3990
Classification name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Joseph Basore
Address
7loveton Cir. Sparks MD US 21152 21152

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PCH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation2026-05-19
K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH2026-03-09
K251721Xpert GI PanelCepheid2026-01-16
K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH2025-10-22
K251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.2025-09-25
K251868Panther Fusion GI Bacterial AssayHologic2025-09-25
K250324QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH2025-02-28
K243885BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidBiofire Diagnostics, LLC2025-01-16
K242877BioCode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc.2025-01-10
K243813QIAstat-Dx GI Panel 2 Mini B&VQIAGEN GmbH2025-01-08
K242367BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC2024-11-07
K220062QIAstat-Dx Gastrointestinal Panel 2QIAGEN GmbH2024-05-31
K232672EasyScreen Gastrointestinal Parasite Detection KitGenetic Signatures Limited2024-05-29
K230404BIOFIRE FILMARRAY Gastrointestinal (GI) PanelBiofire Diagnostics, LLC2023-03-16
K220607BD MAX Enteric Viral PanelBecton, Dickinson and Company2022-09-21

Legacy Summary#

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FDA Review#

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