Exact Science, Inc.
Country not established
- Devices
- 1
What Exact Science, Inc. makes
Exact Science, Inc. manufactures the EXACT ONE™ Hematology Analyzer, a device designed for automated blood cell analysis to measure and differentiate complete blood counts (CBC) and other hematological parameters from whole blood samples.
The EXACT ONE™ Hematology Analyzer is classified as a Class II medical device in the United States and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Exact One(Tm) Hematology Analyzer Ref K900276
510(k) 510(k)
Frequently asked questions
How many devices does Exact Science, Inc. have in the registry?
The registry currently lists 1 device for Exact Science, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Exact Science, Inc.'s devices?
Among its 1 most recently registered device, Exact Science, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Exact Science, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Exact Science, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Exact Science, Inc. in the registry?
The most recently registered devices listed for Exact Science, Inc. include EXACT ONE(TM) HEMATOLOGY ANALYZER.