Data / Medical devices / United States / MEDTOX Diagnostics, Inc.
MEDTOX Diagnostics, Inc.: FDA-registered device maker in Pleasanton, CA, United States, 2 510(k) clearances
MEDTOX Diagnostics, Inc. is registered with the FDA (registration 3011260354) in Pleasanton, CA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 17, 2017. 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
- 3011260354
- Address
- 6624 Owens Drive, Pleasanton, CA, United States, 94588
- Owner or operator
- MEDTOX DIAGNOSTICS, INC. (1050155)
- Roles
- Manufacturer
- First device listed
- October 21, 2021
- Registered through
- 2026
- Brand names listed
- Labcorp Comfort Draw, Torq MiniDrive2, Torq ZDrive MR, BD Microtainer, Torq ZDrive MR, Ram Scientific, TrueSpin
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Manufacturer | accessdata.fda.gov |
| Semen Analysis Device | POV | 2 | Manufacturer | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | 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 |
|---|---|---|---|---|---|---|
| November 17, 2017 | K172514 | Trak Plus Male Fertility Testing System | POV | Substantially Equivalent | Sandstone Diagnostics, Inc. | accessdata.fda.gov |
| May 16, 2016 | K153683 | Trak Male Fertility Testing System | POV | Substantially Equivalent | Sandstone Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Semen Analysis Device
- All makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- All makers of System, Blood Collection, Vacuum-Assisted, Manual
Updated November 17, 2017. 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.