Scientific Standards, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Scientific Standards, Inc. makes
Scientific Standards, Inc. manufactures hematology quality control mixtures, which are used to monitor and validate the performance of blood cell analyzers in clinical laboratories. Their TRI-CHECK product is a specialized control designed to assess the accuracy and precision of automated hematology systems, ensuring reliable diagnostic results.
The company’s portfolio is classified under FDA’s Class II medical devices and is listed in the FDA’s 510(k) registry. These devices are regulated under the US Food and Drug Administration’s premarket notification process, requiring clearance before commercial distribution. The manufacturer is based in the United States.
Catalogue
Hemotology Quality Control Mixtures Ref K810756
Regimes: 510(k) Registry: 510(k)Tri-Check Ref K800938
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Scientific Standards, Inc. have in the registry?
The registry currently lists 2 devices for Scientific Standards, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scientific Standards, Inc.'s devices?
Among its 2 most recently registered devices, Scientific Standards, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Scientific Standards, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Scientific Standards, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scientific Standards, Inc. in the registry?
The most recently registered devices listed for Scientific Standards, Inc. include HEMOTOLOGY QUALITY CONTROL MIXTURES and TRI-CHECK.