The first FDA approval of dialyzers produced in Ronneby

Althin Medical AB has got its first FDA approval of dialyzers produced in Ronneby As a result of the decision to concentrate the production of dialyzers to Ronneby, Althin Medical AB has applied for approval from the American regulatory authority, FDA, to sell six of its dialyzers produced in Ronneby on the US market. Two of the six dialyzers [510(k)], A-15 and A-18, have now been approved by the FDA. These products cover 2/3 of Althin Medical's dialyzer sales in Europe. Althin Medical AB has previously got an FDA approval for its Powder bicarbonate cartridges, Altracart II, and together with the new approval Althin Medical AB now has four products that are approved to be sold on the US market. The four remaining dialyzers are expected to be approved by the FDA by the end of this year. The transfer of dialyzer production from Miami to Ronneby continues as planned and is estimated to be completed in November. Althin Medical AB (publ.) September 29, 1999 Althin Medical AB is an international medical technology group with its main business within the area of hemodialysis. The Althin Group´s products are sold through a worldwide organization which covers approximately 70 countries using 13 of its own companies and around 50 distributors. For further information please contact Mr Otto Svensson at the following telephone numbers: +46 (0)457 759 47 or +46 (0)708 759 479 ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/1999/09/29/19990929BIT00540/bit0001.doc http://www.bit.se/bitonline/1999/09/29/19990929BIT00540/bit0002.pdf