Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015489159

FEI Number

3015489159

Entity Name

ALOM Technologies Corporation

City/State/Country

Indianapolis, IN, US

Establishment Address

3910 Waldemere Avenue, Indianapolis, IN 46241, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ALOM TECHNOLOGIES CORPORATION (Owner Number: 9063998)

Owner / Operator Contact Address

48021 WARM SPRINGS BLVD., --, Fremont, CA 94539, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Genetic variant detection and health risk assessment system Color Diagnostics The TeleRPM Scale Gen 2 (model GBS-2104-G) iGlucose Blood Glucose Monitoring System Blood Pressure Monitor (tmb-2092-G)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTA	Genetic Variant Detection And Health Risk Assessment System	Immunology	Class 2	866.5950	2020-04-06
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2022-10-24
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2025-01-09
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2025-01-10
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-01-09

Official Correspondent

Hannah Kain

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ALOM TECHNOLOGIES CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004597845	ALOM TECHNOLOGIES CORPORATION	FREMONT, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150396	Apex BioTechnology Corp.	Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips	2015-10-14
K150833	Andon Health Co, Ltd.	iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System	2015-12-04
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001

Similar Registrations

Registration Number	Establishment Name	Location
3003436513	ASURAGEN, INC.	AUSTIN, TX, US
3004597845	ALOM TECHNOLOGIES CORPORATION	FREMONT, CA, US
3035380687	TARGETED GENOMICS, LLC	Irvine, CA, US
3038181305	FORTUNA HELIX	Seoul, KR
3018077536	SUPERA FULFILLMENT LLC	Houston, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015489159. Last updated year: 2026. Please use registration number 3015489159 when referencing this establishment in official correspondence.