Decision Diagnostics Corp (DECN)

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Companies that design, manufacture, repackage, relabel, and/or import medical devices into the United States are regulated by FDA's Center for Devices and Radiological Health (CDRH).

The owner of the device/product could have designed it, but then had it manufactured by a contract manufacturer.

Do You Know…
What It Means When FDA "Clears" or "Approves" a Medical Device?

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm193731.htm