Chromatics Color Sciences files response to FDA request.NEW YORK--(BUSINESS WIRE)--May 27, 1997--Chromatics Color Sciences International Inc. filed its response to an April 25, 1997 request (confirmed by an April 29, 1997 letter) from the Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. (CDRH CDRH Center for Devices and Radiological Health (US FDA) ), Food and Drug Administration (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. ), asking for additional information as part of the agency's review of Chromatics' premarket notification (510(k)) submission regarding the company's Colormate(TM) device for non-invasive monitoring of bilirubin infant jaundice. The company responded to the FDA request within the required 30-day period ending May 29, 1997. The company is engaged in the business of color science, including the scientific color measurement and classification of human skin, certain color-sensitive consumer products, and in determining the color compatibility of such skin and product color classification for use in a variety of industries including the cosmetic, beauty aid and fashion industries, as well as technology development for potential medical applications involving the detection and monitoring of certain chromogenic chro·mo·gen·ic adj. Of or relating to a chromogen or to chromogenesis. chromogenic (krō´mōjen´ik), adj pertaining to color production. diseases. The company's common stock and warrants are traded on NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on under the symbols "CCSI CCSI Computer & Control Solutions, Inc CCSI Cisco Certified Systems Instructor (training qualification) CCSI Canadian Centre for Swine Improvement CCSI Contemporary Control Systems, Inc CCSI Channel Coding with Side Information " and "CCSIW", respectively. Certain of the matters discussed are forward-looking statements that involve material risks to and uncertainties in the company's business which may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include, among other things, the availability of any needed financing, the company's ability to implement its long range business plan for various applications for its technologies, the impact of competition, the obtaining of and compliance with regulatory approvals applicable to proposed application of the company's technology, management of growth, and other risks and uncertainties that may be detailed from time to time in the company's reports filed with the Securities and Exchange Commission, including those set forth in it's annual report on Form 10-KSB. CONTACT: Chromatics chro·mat·ics n. (used with a sing. verb) The scientific study of color. chro  ma·tist n. Color Sciences International, New York Darby S. Macfarlane 212/717-6544 212/717-6675 (fax) |
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