Standard Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Standard Diagnostics, Inc. makes
Standard Diagnostics, Inc. manufactures diagnostic test kits, including the GOOD MORNING TEST for at-home health assessments, and the SMARTLINK GOLD Blood Glucose Monitoring System for continuous glucose tracking. The company also produces the SD CHECK GOLD, a laboratory-style diagnostic device for clinical use.
These products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) clearance pathway. The company is based in the United States and its devices are listed in the FDA’s 510(k) registry.
Catalogue
Good Morning Test Ref K031798
Regimes: 510(k) Registry: 510(k)Smartlink Gold Blood Glucose Monitoring System Ref K100398
Regimes: 510(k) Registry: 510(k)Sd Check Gold Ref K082683
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Standard Diagnostics, Inc. have in the registry?
The registry currently lists 3 devices for Standard Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Standard Diagnostics, Inc.'s devices?
Among its 3 most recently registered devices, Standard Diagnostics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Standard Diagnostics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Standard Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Standard Diagnostics, Inc. in the registry?
The most recently registered devices listed for Standard Diagnostics, Inc. include GOOD MORNING TEST, SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM and SD CHECK GOLD.