notification (ie, 510(k) clearance) is a general control, most Class I devices are exempt from premarket
notification and are not reviewed by FDA before they can be legally marketed.
52 in premarket
after it reported quarterly results and said it signed up fewer video-streaming subscribers than forecast for the quarter.
Penney lead a string of retailers posting results, and their shares all rose in premarket
8 percent in premarket
trading after its board has approved a deal to buy blogging and social networking site Tumblr for $1.
27, 2013 /PRNewswire/ -- ConvergEx Group , a leading technology company, today announced that it is now offering a new premarket
trading algorithm that allows customers to capture liquidity outside of traditional market hours.
Heinz Co shares jumped 20 percent in premarket
trading after it said that Warren Buffett's Berkshire Hathaway and 3G Capital will buy the company for $72.
47 looks a match between heat winners PREMARKET
OLLY and Denwill Star.
Food and Drug Administration has announced two new training programs designed to improve the skills of premarket
application reviewers at the Center for Devices and Radiological Health (CDRH).
Companies will be required to pay $4,049 per 510(k) premarket
submission, compared with the $4,348 they paid this year.
financials opened with strong gains Tuesday, boosted by solid earnings results and positive housing data released premarket
Unless exempt by regulation, new devices must clear FDA premarket
review via either the 510(k) premarket
notification process, which determines if a new device is substantially equivalent to another legally marketed device, or the more stringent premarket
approval (PMA) process, which requires the manufacturer to supply evidence providing reasonable assurance that the device is safe and effective.
Some High Point exhibitors say the number of furniture buyers in town for unofficial premarket
events was down 10 percent or more Sept.