Hemotec, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
What Hemotec, Inc. makes
Hemotec, Inc. manufactures coagulation testing systems and related consumables, including whole blood coagulation analyzers like the HEPCOL System B-10, HEPCON/SYSTEM RC-10, and ACT I System. Their portfolio also includes coagulation controls, heparinase-treated controls, and specialized reagents such as calcium chloride solutions and heparin assay cartridges. These devices are designed for laboratory use to monitor clotting parameters in whole blood samples.
The company’s coagulation testing systems and controls are classified as Class II medical devices under FDA regulations, with most products cleared via the 510(k) pathway. These devices are intended for use in clinical laboratories and are listed in the FDA’s 510(k) database. Hemotec, Inc. is based in the United States.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Hemotec, Inc. have in the registry?
The registry currently lists 15 devices for Hemotec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hemotec, Inc.'s devices?
Among its 15 most recently registered devices, Hemotec, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Hemotec, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Hemotec, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hemotec, Inc. in the registry?
The most recently registered devices listed for Hemotec, Inc. include HEPCOL SYSTEM B-10 & B-10-P, HEPCON/SYSTEM RC-10, HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS and HEMOTEC ACT I SYSTEM.