Horizon Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Horizon Diagnostics, Inc. makes
Horizon Diagnostics, Inc. manufactures in-vitro diagnostic reagent sets for clinical laboratory use, including reagents for measuring triglycerides, amylase, direct bilirubin, iron/total iron-binding capacity (TIBC), creatine kinase-MB, and blood urea nitrogen (BUN). These products are designed for automated chemistry analyzers to support routine biochemical testing in healthcare settings.
The company’s portfolio includes Class I and Class II in-vitro diagnostic reagents, regulated under the FDA’s 510(k) clearance pathway. These products are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the United States.
Catalogue
Horizon Diagnostics Triglycerides-Gpo Reagent Ref K933722
Regimes: 510(k) Registry: 510(k)Amylase Ref K930678
Regimes: 510(k) Registry: 510(k)Direct Bilirubin Ref K930679
Regimes: 510(k) Registry: 510(k)In-Vitro Diagnostic Reagent Set Ref K930074
Regimes: 510(k) Registry: 510(k)Iron/Tibc Reagent Ref K935712
Regimes: 510(k) Registry: 510(k)Creatine Kinase-Mb Reagent Set Ref K971566
Regimes: 510(k) Registry: 510(k)Bun-300/Bun-500 Urea Nitrogen Reagent Ref K934533
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Horizon Diagnostics, Inc. have in the registry?
The registry currently lists 7 devices for Horizon Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Horizon Diagnostics, Inc.'s devices?
Among its 7 most recently registered devices, Horizon Diagnostics, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Horizon Diagnostics, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Horizon Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Horizon Diagnostics, Inc. in the registry?
The most recently registered devices listed for Horizon Diagnostics, Inc. include HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT, AMYLASE, DIRECT BILIRUBIN and IN-VITRO DIAGNOSTIC REAGENT SET.