To: Shoot1st who wrote (14205 ) 5/4/1998 4:14:00 PM From: Money Maker (MM) Read Replies (2) | Respond to of 34592
Biocontrol Updates CE Mark Application Progress (4/29 news)biz.yahoo.com PITTSBURGH, April 29 /PRNewswire/ -- Biocontrol Technology, Inc. (Nasdaq: BICO - news) announced today that progress continues toward obtaining a CE Mark for the Diasensor(R) 1000 noninvasive glucose sensor. Its Notified Body, TUV Rheinland Product Safety GmbH, Germany, has reviewed Biocontrol's recently submitted Technical File and requested some clarification and information on certain points. Such reciprocation is an expected part of CE Mark Technical File reviews, and Biocontrol expects to fulfill the requests next week. When supplied, the requested information should further clarify the Technical File and assist TUV in their review of the Diasensor 1000 for CE Marking. TUV will then respond to Biocontrol's CE Mark application as soon as the review is completed. When achieved, the CE Mark on the Diasensor will signify that the product meets the mandatory health and safety requirements to be marketed in the 15-member European Union (EU) with a diabetic population of approximately 15 million. The first two steps in obtaining the CE Mark were completed by the Company in October 1997 and January 1998 resulting in ISO 9001 registration for its Indiana, PA manufacturing and product development facilities. Biocontrol Technology, Inc. (www.bico.com) has its corporate offices in Pittsburgh, PA and is involved in the development and manufacture of biomedical devices and environmental products. This press release contains statements of a forward looking nature. Shareholders and potential investors are cautioned that such statements are predictions and actual events or results may vary significantly. SOURCE: Biocontrol Technology, Inc.