510(k) K050591

MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS by Raven Biological Laboratories, Inc. — Product Code FRC

K050591 is an FDA 510(k) premarket notification submitted by Raven Biological Laboratories, Inc. for the device "MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS". The FDA issued a decision of Substantially Equivalent on March 23, 2005. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Raven Biological Laboratories, Inc. has at least 10 other 510(k) clearances on record.