Press Releases

(SANYO Electric Biomedical Co., Ltd., Osaka, Japan, (distributed by SANYO Biomedical, Bensenville, IL), 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.

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 MCO-17AC, MCO-17AIC and MCO-20AIC Series chambers constructed of SANYO inCu saFe™ 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 most advanced Model MCO-20AIC cell culture incubator includes the integration of newly patented technologies such as SafeCellÔ narrow bandwidth ultraviolet light and Direct Heat, Air temperature and humidity systems to create Active Background Contamination ControlÔ 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 summarized:

• 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
• Dated: October 30, 2001

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, cryogenic freezers, biomedical, pharmacy and medical refrigerators, cell culture and orbital incubators and centrifuges.

SANYO Electric Biomedical Co., Ltd., is headquartered in Osaka, Japan, and distributed in the U.S. by SANYO Biomedical, Bensenville, IL. For product information, call SANYO Biomedical at (800) 858-8442.

Contact: Chris Stannard, cstannard@sss.sanyo.com