AVAILS MEDICAL, INC.

FDA Device Registration & Listing · Menlo Park, CA, US · Registration 3035367039

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3035367039
FEI Number
3035367039
Entity Name
AVAILS MEDICAL, INC.
City/State/Country
Menlo Park, CA, US
Establishment Address
1080 OBrien Drive, Suite A, Menlo Park, CA 94025, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Avails Medical, Inc. (Owner Number: 10092380)
Owner / Operator Contact Address
1080 OBrien Drive, Suite A, Menlo Park, CA 94025, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231536
PMA Number
N/A

All Registered Proprietary Names

eQUANT System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QZX Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing Microbiology Class 2 866.1650 2024-12-30
JTN Susceptibility Test Discs, Antimicrobial Microbiology Class 2 866.1620 2024-12-30

Official Correspondent

Ruchi Shah

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Avails Medical, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K002664 Hardy Diagnostics HARDYDISK LEVOFLOXACIN, 5MCG 2000-10-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035367039. Last updated year: 2026. Please use registration number 3035367039 when referencing this establishment in official correspondence.
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