ARTRON LABORATORIES INC.

FDA Device Registration & Listing · Burnaby British Columbia, CA · Registration 3005445066

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
3005445066
FEI Number
3005445066
Entity Name
ARTRON LABORATORIES INC.
City/State/Country
Burnaby British Columbia, CA
Establishment Address
3938 North Fraser Way, Burnaby British Columbia V5J 5H6, CA
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Artron Laboratories Inc. (Owner Number: 10045485)
Owner / Operator Contact Address
3938 North Fraser Way, Burnaby, CA-BC V5J 5H6, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K060019
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2013-11-21
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2013-11-21

Official Correspondent

Helen Ke

US Agent Details

Pierce Liu Business: Keva Inc. Email: info@kevadx.com Phone: (360) 6841217

Related Public Records

Same Entity

Artron Laboratories 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
K964108 Direct Access Diagnostics FACT PLUS PREGNANCY TEST 1996-11-18
K945514 Princeton BioMeditech Corp. LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG 1995-02-10
K150022 Guangzhou Wondfo Biotech Co., Ltd. Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream 2015-08-07
K043443 Guangzhou Wondfo Biotech Co., Ltd. ONE STEP HCG URINE PREGNANCY TEST 2005-04-08
K173229 Guangzhou Wondfo Biotech Co., Ltd. Preview Digital Pregnancy Test 2018-03-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0042-2024 Universal Meditech Inc. 2
One Step Pregnancy Test REF 100-01
Z-0006-05 Abbott Health Products, Inc. 2
AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005445066. Last updated year: 2026. Please use registration number 3005445066 when referencing this establishment in official correspondence.
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