Daxor announces completion of additional tests on Patented Quantitative injection syringe; Submits data to FDA.NEW YORK--(BUSINESS WIRE)--May 28, 1997--On Feb. 4, 1997, the company filed a 510(k) application for a quantitative injection syringe syringe /sy·ringe/ (si-rinj´) (sir´inj) an instrument for injecting liquids into or withdrawing them from any vessel or cavity. to be used in conjunction with its patented blood volume analyzer analyzer /ana·ly·zer/ (an´ah-li?zer) 1. a Nicol prism attached to a polarizing apparatus which extinguishes the ray of light polarized by the polarizer. 2. . Measurement of blood volume involves a precise almost complete injection of the tracer isotope isotope (ī`sətōp), in chemistry and physics, one of two or more atoms having the same atomic number but differing in atomic weight and mass number. The concept of isotope was introduced by F. . Prior to the 510(k) filing the company had initiated a search for a suitable manufacturer to act as a prime contractor and to complete the design of the syringe. On May 2, 1997 the company contracted with Wellport a Rochester, N.Y. manufacturer specializing in custom design and development of medical disposable devices. The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , on April 29, 1997 had contacted the company regarding some clarification in the 510(k) application and additional performance data. The company was given 30 days to respond or request an extension of the time period. Wellport was able to produce a number of customized prototype syringes within a week. The requested tests on the syringes has been completed and the additional tests and other data have been submitted to the FDA on May 27, 1997. This was accomplished within the 30 day period without requesting an extension. For additional information please contact Andrea Webber or Dr. Joseph Feldschuh, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . CONTACT: Daxor Corp., New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of Andrea Webber or Dr. Joseph Feldschuh, 212/244-0555 |
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