Data / Medical devices / Canada / Artron Laboratories Inc.
Artron Laboratories Inc.: FDA-registered device maker in Burnaby British Columbia, Canada, 1 510(k) clearance
Artron Laboratories Inc. is registered with the FDA (registration 3005445066) in Burnaby British Columbia, Canada. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 17, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005445066
- Address
- 3938 North Fraser Way, Burnaby British Columbia, Canada, V5J 5H6
- Owner or operator
- Artron Laboratories Inc. (10045485)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 21, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Manufacturer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 17, 2006 | K060019 | ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM) | LCX | Substantially Equivalent | Artron Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Visual, Pregnancy Hcg, Prescription Use
Updated February 17, 2006. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.