510(k) K031114

PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA by Raven Biological Laboratories, Inc. — Product Code MRB

K031114 is an FDA 510(k) premarket notification submitted by Raven Biological Laboratories, Inc. for the device "PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA". The FDA issued a decision of Substantially Equivalent on March 3, 2004. The device falls under product code MRB (Indicator, Biological, Liquid Chemical 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.