American Scientific Resources (ASFX)

[carjac]

My bad.

From the S-1:

"The first units off the tooling have been submitted for testing to ensure they meet ASTM standards (American Society of Testing and Materials); the Company received a passing grade from ASTM in May 2010 (when ASTM tests products to ensure they meet ASTM’s standards, ASTM provides either a pass or fail grade). Concurrently, a required premarket notification, known as a 510(k), was filed with the FDA. A predicate device manufactured by this Chinese company already has an FDA approval, so no further clinical trials are required. The Company has engaged an FDA consultant to help guide it through the 510(k) filing process."


However, it appears to be just a formality.