Sandstone Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Sandstone Diagnostics, Inc. makes
Sandstone Diagnostics, Inc. manufactures in vitro diagnostic devices for male fertility testing, including the Trak Plus Male Fertility Testing System and the Trak Male Fertility Testing System. These systems are designed to analyze semen samples for key fertility parameters, such as sperm concentration, motility, and morphology, supporting reproductive health assessments.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance. The portfolio is regulated in the United States, where the manufacturer is based.
Catalogue
Trak Plus Male Fertility Testing System Ref K172514
Regimes: 510(k) Registry: 510(k)Trak Male Fertility Testing System Ref K153683
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sandstone Diagnostics, Inc. have in the registry?
The registry currently lists 2 devices for Sandstone Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sandstone Diagnostics, Inc.'s devices?
Among its 2 most recently registered devices, Sandstone Diagnostics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Sandstone Diagnostics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sandstone Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sandstone Diagnostics, Inc. in the registry?
The most recently registered devices listed for Sandstone Diagnostics, Inc. include Trak Plus Male Fertility Testing System and Trak Male Fertility Testing System.