Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004597845

FEI Number

3004597845

Entity Name

ALOM TECHNOLOGIES CORPORATION

City/State/Country

FREMONT, CA, US

Establishment Address

48105 Warm Springs Blvd, FREMONT, CA 94539, 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

Invitae Saliva Collection kit Genetic variant detection and health risk assessment system Molekule Air Mini, Molekule Air Mini + Invitae Non-Invasive Prenatal Screen (NIPS) Collection Kit Color Diagnostics

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2023-05-15
PTA	Genetic Variant Detection And Health Risk Assessment System	Immunology	Class 2	866.5950	2020-04-06
FRA	Purifier, Air, Ultraviolet, Medical	General Hospital	Class 2	880.6500	2021-03-02
QMA	Blood Collection Device For Cell-Free Nucleic Acid	Clinical Chemistry	Class 2	862.1676	2023-05-15
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2022-10-24

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
3015489159	ALOM Technologies Corporation	Indianapolis, IN, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004597845. Last updated year: 2026. Please use registration number 3004597845 when referencing this establishment in official correspondence.