Esa, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Esa, Inc. makes
Esa, Inc. manufactures diagnostic devices for neurochemical and heavy metal analysis, including plasma-free metanephrine testing kits, continuous electroanalytical systems (CEAS) for neurochemical monitoring, and blood lead testing systems. Their portfolio includes analyzers like the COULOCHEM II and electrode array systems for electrochemical assays, as well as point-of-care solutions for detecting lead exposure.
The company’s devices are regulated under FDA’s 510(k) pathway, with products classified as Class I and Class II. These devices are listed in the FDA’s 510(k) clearance registry, and the company operates from the United States.
Catalogue
Esa Plasma Free Metanephrine Analysis Kit Ref K032199
Regimes: 510(k) Registry: 510(k)Model 5500 Ceas Ref K963938
Regimes: 510(k) Registry: 510(k)Neurochemical Analyzer Ref K864729
Regimes: 510(k) Registry: 510(k)Model 5500 Ceas Ref K934977
Regimes: 510(k) Registry: 510(k)Coulochem Ii Ref K903231
Regimes: 510(k) Registry: 510(k)Model 5500 Coulochem Electrode Array System Ref K931148
Regimes: 510(k) Registry: 510(k)Leadcare Blood Lead Testing System Ref K971640
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Esa, Inc. have in the registry?
The registry currently lists 7 devices for Esa, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Esa, Inc.'s devices?
Among its 7 most recently registered devices, Esa, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Esa, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Esa, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Esa, Inc. in the registry?
The most recently registered devices listed for Esa, Inc. include ESA PLASMA FREE METANEPHRINE ANALYSIS KIT, MODEL 5500 CEAS, NEUROCHEMICAL ANALYZER and COULOCHEM II.