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510(k) K223493

Device
PBC Separator with Selux AST System
Applicant
Selux Diagnostics, Inc.
510(k) number
K223493
Product code
QZX
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-15
Date received
2022-11-21
Regulation
866.1650
Classification name
Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Eric Stern
Address
56 Roland St. Suite 206 Charlestown MA US 02129 02129

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QZX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K244044PBC Separator with Selux AST SystemSelux Diagnostics, Inc.2025-03-28
K231536eQUANT SystemAvails Medical, Inc.2024-02-08