Zdrowie i gospodarka · 11/05/2004

FDA Classifies Immunomagnetic Circulating Cancer Cell Selection and Enumeration System Device into Class II with Special Controls

The FDA has classified the Immunomagnetic Circulating Cancer Cell Selection and Enumeration System device into Class II, requiring special controls, in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act, as amended by various medical device amendments, to ensure a reasonable assurance of safety and effectiveness.