510(k) K012335

BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS by Albert Browne , Ltd. — Product Code JOJ

K012335 is an FDA 510(k) premarket notification submitted by Albert Browne , Ltd. for the device "BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS". The FDA issued a decision of Substantially Equivalent on October 1, 2001. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Albert Browne , Ltd. has at least 10 other 510(k) clearances on record.