Enzymatics C/O Burditt, Bowles, Radzius & Ruberry
Country not established
- Devices
- 3
What Enzymatics C/O Burditt, Bowles, Radzius & Ruberry makes
Enzymatics produces saliva-based alcohol testing devices, including the STATLAB A-350, and laboratory test kits for measuring total cholesterol levels. These products are designed for point-of-care and clinical diagnostic use to detect alcohol presence and quantify cholesterol concentrations in biological samples.
The company’s portfolio includes devices classified under FDA’s Class I and Class II categories, with regulatory submissions supported by 510(k) clearances. These products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Statlab A-350 Saliva Alcohol Test Ref K903235
Regimes: 510(k) Registry: 510(k)Saliva Alcohol Test Ref K894001
Regimes: 510(k) Registry: 510(k)Enzymatics, Inc., Total Cholesterol Test Ref K911692
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Enzymatics C/O Burditt, Bowles, Radzius & Ruberry have in the registry?
The registry currently lists 3 devices for Enzymatics C/O Burditt, Bowles, Radzius & Ruberry. Devices recorded under merged duplicate company entries are counted once.
Which registries list Enzymatics C/O Burditt, Bowles, Radzius & Ruberry's devices?
Among its 3 most recently registered devices, Enzymatics C/O Burditt, Bowles, Radzius & Ruberry has devices listed in FDA 510(k) (3 devices).
What risk classes do Enzymatics C/O Burditt, Bowles, Radzius & Ruberry's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Enzymatics C/O Burditt, Bowles, Radzius & Ruberry's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Enzymatics C/O Burditt, Bowles, Radzius & Ruberry in the registry?
The most recently registered devices listed for Enzymatics C/O Burditt, Bowles, Radzius & Ruberry include STATLAB A-350 SALIVA ALCOHOL TEST, SALIVA ALCOHOL TEST and ENZYMATICS, INC., TOTAL CHOLESTEROL TEST.