Data / Medical devices / Canada / Healstone Biotech Inc.
Healstone Biotech Inc.: FDA-registered device maker in Vancouver British Columbia, Canada, 3 510(k) clearances
Healstone Biotech Inc. is registered with the FDA (registration 3014301129) in Vancouver British Columbia, Canada. It lists 13 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 30, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014301129
- Address
- Unit #650 - 655 West Kent Avenue North, Vancouver British Columbia, Canada, V6P 6T7
- Owner or operator
- Healstone Biotech Inc. (10056764)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 25, 2018
- Registered through
- 2026
- Brand names listed
- Abbott iSCREEN URINE TEST DRUG SCREEN CLICK CUP, Abbott iSCREEN URINE TEST DRUG SCREEN FLAT CUP, Healstone Accurate Drug of Abuse Urine Test Cup, Healstone Biotech Inc. Accurate Multi Panel Drug Urine Test Cup, Healstone LH Rapid Test, Healstone hCG One Step Pregnancy Test, Rite Aid Corporation Rite Aid Drug Test Kit
Devices it lists
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 |
|---|---|---|---|---|---|---|
| August 30, 2022 | K221871 | Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx | NFT | Substantially Equivalent | Healstone Biotech, Inc. | accessdata.fda.gov |
| June 30, 2022 | K212418 | hCG One Step Pregnancy Test | LCX | Substantially Equivalent | Healstone Biotech, Inc. | accessdata.fda.gov |
| August 7, 2019 | K191841 | Accurate Multi Panel Drug Urine Test Cup | NFT | Substantially Equivalent | Healstone Biotech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Test, Amphetamine, Over The Counter
- All makers of Test, Opiates, Over The Counter
- All makers of Test, Cannabinoid, Over The Counter
- All makers of Test, Methamphetamine, Over The Counter
Updated August 30, 2022. 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.