510(k) K050664

SPOR-TEST PA BIOLOGICAL INDICATOR KIT by Getinge USA, Inc. — Product Code FRC

K050664 is an FDA 510(k) premarket notification submitted by Getinge USA, Inc. for the device "SPOR-TEST PA BIOLOGICAL INDICATOR KIT". The FDA issued a decision of Substantially Equivalent on April 7, 2005. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Getinge USA, Inc. has at least 3 other 510(k) clearances on record.