Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004869564

FEI Number

3004869564

Entity Name

Aspira Women's Health, Inc.

City/State/Country

Austin, TX, US

Establishment Address

12117 FM2244 #3 suite 100, Austin, TX 78738, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Aspira Women's Health (Owner Number: 9077721)

Owner / Operator Contact Address

12117 FM2244 #3 suite 100, Austin, TX 78738, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150588

PMA Number

N/A

All Registered Proprietary Names

OVA 1 Test Overa

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONX	Ovarian Adnexal Mass Assessment Score Test System	Obstetrics/Gynecology	Class 2	866.6050	2009-12-29
ONX	Ovarian Adnexal Mass Assessment Score Test System	Obstetrics/Gynecology	Class 2	866.6050	2019-08-22

Official Correspondent

Silvana Franco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Aspira Women's Health

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3005333358	ABBOTT LABORATORIES	Lake Forest, IL, US
2521625	Fujirebio Diagnostics, Inc.	Malvern, PA, US
1415939	ABBOTT LABORATORIES	Abbott Park, IL, US
3002809144	ABBOTT GmbH	Wiesbaden Hesse, DE
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004869564. Last updated year: 2026. Please use registration number 3004869564 when referencing this establishment in official correspondence.