Somas Medical Industries, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Somas Medical Industries, Inc. makes
Somas Medical Industries, Inc. manufactures diagnostic reagents and controls for laboratory testing, including spinal fluid and urine controls, total bilirubin assay reagents, total protein assays, and iron/iron-binding capacity test kits. These products are designed for use in clinical chemistry and hematology to support accurate measurement of biomarkers like chloride, protein, and iron levels.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded via the 510(k) pathway. Products are listed in the FDA’s regulatory database, and the company operates from the United States.
Catalogue
Somas Human Spinal Fluid Control Ref K840974
Regimes: 510(k) Registry: 510(k)Total Bilirubin Reagent Ref K840486
Regimes: 510(k) Registry: 510(k)Somas Coomasie Blue Total Protein Assay Ref K842134
Regimes: 510(k) Registry: 510(k)Somas Liquid Urine Control Ref K862179
Regimes: 510(k) Registry: 510(k)Total Iron Uibc/Tibc Assay Ref K840485
Regimes: 510(k) Registry: 510(k)Somas Chloride Assay Kit Ref K833787
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Somas Medical Industries, Inc. have in the registry?
The registry currently lists 6 devices for Somas Medical Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Somas Medical Industries, Inc.'s devices?
Among its 6 most recently registered devices, Somas Medical Industries, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Somas Medical Industries, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Somas Medical Industries, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Somas Medical Industries, Inc. in the registry?
The most recently registered devices listed for Somas Medical Industries, Inc. include SOMAS HUMAN SPINAL FLUID CONTROL, TOTAL BILIRUBIN REAGENT, SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY and SOMAS LIQUID URINE CONTROL.