Data / Medical devices / United States / Lochness Medical
Lochness Medical: FDA-registered device maker in Buffalo, NY, United States, 5 510(k) clearances
Lochness Medical is registered with the FDA (registration 3008741972) in Buffalo, NY, United States. It lists 13 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008741972
- Address
- 2775 Broadway, Buffalo, NY, United States, 14227
- Owner or operator
- BTNX Inc. (9058575)
- Roles
- Complaint file establishment
- First device listed
- July 8, 2025
- Registered through
- 2026
- Brand names listed
- Rapid Response Drug Monitoring Cup, Rapid Response Drug Monitoring Panel, Rapid Response Drug Test Cup, Rapid Response Drug Test Panel, Rapid Response Home Drug Monitoring Cup, Rapid Response Home Drug Monitoring Panel, Rapid Response Home Drug Test Cup, Rapid Response Home Drug Test Panel and more
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 15, 2025 | K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup | NFT | Substantially Equivalent | Assure Tech., LLC | accessdata.fda.gov |
| February 27, 2025 | K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | NFT | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| February 7, 2025 | K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup | NFT | Substantially Equivalent | Assure Tech., LLC | accessdata.fda.gov |
| November 2, 2023 | K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx | NFT | Substantially Equivalent | Vivachek Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| November 10, 2022 | K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | NFT | Substantially Equivalent | Vivachek Biotech (Hangzhou) Co., Ltd. | accessdata.fda.gov |
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Updated August 15, 2025. 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.