SANYO Biomedical Europe BV : CO2 Incubators Approved by FDA

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SANYO CO2 Incubators Approved by FDA.

SANYO Electric Biomedical Co., Ltd., Osaka, Japan, (distributed by SANYO E&E Europe BV), has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its MCO-Series CO2 and MCO-175M tri-gas laboratory incubators for in vitro fertilization applications. A 510(k) clearance is issued based on formal submission to the FDA in accordance with the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992. This clearance permits SANYO to market its entire line of MCO-Series incubators as "assisted reproduction accessories" required to establish and maintain optimum temperature, CO2 and/or O2, and relative humidity critical to in vitro protocols.

The SANYO laboratory incubator product line includes copper-enriched stainless steel interior surfaces for added protection against growth or proliferation of airborne contaminants such as mycoplasma, molds, yeasts and fungi.

SANYO's MCO-20AIC cell culture model incubator includes the integration of newly patented technologies such as SafeCell narrow bandwidth ultraviolet light and Direct Heat, Air temperature and humidity systems to create Active Background Contamination Control in the cell culture environment. This means users can minimize or eliminate downtime for conventional decontamination which could affect viability of early-stage embryonic cultures.

Details of the FDA 510(k) clearance referenced at http://www.fda.gov/cdrh/510k/sumdec01.html are summarised:

Number: K013703
Trade/Device Name: SANYO CO2 Incubators
Regulation Number: 21 CFR 884-6120
Regulation Name: Assisted Reproduction Accessories
Regulatory Class: II
Product Code: 85 MQG

SANYO Electric Biomedical Co., Ltd., is a global leader in the development of laboratory equipment for pharmaceutical, life science and biotechnology applications. Product lines include space-efficient V.I.P. ultra-low temperature freezers, biomedical, pharmacy and medical refrigerators, cell culture and orbital incubators and centrifuges.