Daxor Corporation files 510(k) application with FDA for injection kit system.NEW YORK--(BUSINESS WIRE)--Feb. 4, 1997--The Daxor Corporation today filed its 510(k) for the quantitative injection syringe syringe /sy·ringe/ (si-rinj´) (sir´inj) an instrument for injecting liquids into or withdrawing them from any vessel or cavity. kit with 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. . In May 1996, Daxor received the first U.S. patent for a quantitative injection syringe which is designed to deliver 99.9%+ of its content. The syringe is designed to be used in conjunction with the 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. (BVA-100) which the Company has developed. The syringe is designed to be utilized in situations where a precise and complete injection is required for diagnostic studies. Measurement of blood volume requires a complete injection of the diagnostic test substance. The quantitative injection syringe was specifically developed for use with the BVA-100 but can be used in other situations where precise quantitative injections are required. The Company's BVA-100 had its 510(k) submitted on November November: see month. 4, 1996, where it is currently under review. CONTACT: Susan Zomper, Esq or Joseph Feldschuh, MD, President & 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. 212/244-0555 |
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