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510(k) K231536

Device
eQUANT System
Applicant
Avails Medical, Inc.
510(k) number
K231536
Product code
QZX
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-08
Date received
2023-05-30
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
Meike Herget
Address
1455 Adams Dr. Suite 1288 Menlo Park CA US 94025 94025

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
K223493PBC Separator with Selux AST SystemSelux Diagnostics, Inc.2024-02-15