510(k) K070419

OPACIDEN OPA REAGENT STRIPS by Hach Company — Product Code JOJ

K070419 is an FDA 510(k) premarket notification submitted by Hach Company for the device "OPACIDEN OPA REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on August 31, 2007. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Hach Company has at least 3 other 510(k) clearances on record.