Chemtrak, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Chemtrak, Inc. makes
Chemtrak, Inc. manufactures point-of-care diagnostic devices, including cholesterol testing strips (HDL and self-test formats), a theophylline test strip, and a Helicobacter pylori test strip. These products are designed for rapid, in-clinic or home-based measurement of specific biomarkers.
The company’s devices are classified as Class I and Class II under FDA regulations, with most submissions recorded via the 510(k) pathway. They are listed in the FDA’s 510(k) database and operate under US regulatory oversight.
Catalogue
Accumeter Hdl Cholesterol Test Ref K943279
Regimes: 510(k) Registry: 510(k)Chemtrak Accumeter Cholesterol Test Ref K905405
Regimes: 510(k) Registry: 510(k)Accumeter H. Pylori Test Ref K965099
Regimes: 510(k) Registry: 510(k)Accumeter Theophylline Test Ref K972495
Regimes: 510(k) Registry: 510(k)Accumeter H. Pylori Test Ref K960478
Regimes: 510(k) Registry: 510(k)Accumeter(R) Cholesterol Self-Test Ref K914432
Regimes: 510(k) Registry: 510(k)Chem Trak Accumeter Ref K943599
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Chemtrak, Inc. have in the registry?
The registry currently lists 7 devices for Chemtrak, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Chemtrak, Inc.'s devices?
Among its 7 most recently registered devices, Chemtrak, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Chemtrak, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Chemtrak, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Chemtrak, Inc. in the registry?
The most recently registered devices listed for Chemtrak, Inc. include ACCUMETER HDL CHOLESTEROL TEST, CHEMTRAK ACCUMETER CHOLESTEROL TEST, ACCUMETER H. PYLORI TEST and ACCUMETER THEOPHYLLINE TEST.