Paragon Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Paragon Diagnostics, Inc. makes
Paragon Diagnostics, Inc. manufactures in vitro diagnostic reagents and systems for measuring drug concentrations in patient samples. Their products include assay reagents for theophylline, gentamicin, T4 thyroid hormone, tobramycin, amikacin, and tuberculosis (TBC), alongside the IMMPULSE system for automated testing.
These devices are regulated under FDA 510(k) clearance, with classifications spanning Class I and Class II. The company’s products are listed in the FDA’s 510(k) registry and are based in the United States.
Catalogue
Immpulse Theophylline Assay Reagents Ref K840758
Regimes: 510(k) Registry: 510(k)Immpulse System Ref K834070
Regimes: 510(k) Registry: 510(k)Immpulse Gentamicin Assay Reagents Ref K841162
Regimes: 510(k) Registry: 510(k)Immpulse T4 Assay Reagents Ref K840852
Regimes: 510(k) Registry: 510(k)Immpulse Tobramycin Assay Reagents Ref K840847
Regimes: 510(k) Registry: 510(k)Immpulse Amikacin Assay Reagents Ref K841161
Regimes: 510(k) Registry: 510(k)Immpulse Tbc Assay Reagents Ref K840853
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Paragon Diagnostics, Inc. have in the registry?
The registry currently lists 7 devices for Paragon Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Paragon Diagnostics, Inc.'s devices?
Among its 7 most recently registered devices, Paragon Diagnostics, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Paragon Diagnostics, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Paragon 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 Paragon Diagnostics, Inc. in the registry?
The most recently registered devices listed for Paragon Diagnostics, Inc. include IMMPULSE THEOPHYLLINE ASSAY REAGENTS, IMMPULSE SYSTEM, IMMPULSE GENTAMICIN ASSAY REAGENTS and IMMPULSE T4 ASSAY REAGENTS.