Women's Health Weekly
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Diagnostics
U.S. FDA responds to company's submission for breast cancer diagnostic system
January 13th, 2005
Biofield Corp. (BZET) announced that the U.S. Food and Drug Administration (FDA) has conducted an initial review related to the filing status of the company's 510(k) premarket notification for the Biofield Breast Cancer Diagnostic System (BDS). The FDA informed the company that the BDS, which had been submitted to the FDA as recommended for substantial equivalence consideration by KEMA Registered Quality, Inc., (KEMA) an FDA-sanctioned third-party reviewer, is not substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the medical device amendments, or to any device which is classified into class I (general...
Source: Women's Health Weekly (2005-01-13)
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