K142132-FoodandDrugAdministration.PDFVIP

DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service ____________________________________________________________________________________________________________________________ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002 December 12, 2014 Diagnostica Stago Ms. Marie Compagnon-Riobe Registration Reagent Documentation Manager 125 Avenue Louis Roche 92230 Gennevilliers, France Re: k142132 Trade/Device Name: Pool Norm Plasma Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: GGN Dated: November 4, 2014 Received: November 6, 2014 Dear Ms. Compagnon-Riobe: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general