FDA.report

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
N

Related Records

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)DeviceApplicantDecision date
K244044PBC Separator with Selux AST SystemSelux Diagnostics, Inc.2025-03-28
K223493PBC Separator with Selux AST SystemSelux Diagnostics, Inc.2024-02-15