510(k) K801303

MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST by Western Laboratories Corp. — Product Code KDI

K801303 is an FDA 510(k) premarket notification submitted by Western Laboratories Corp. for the device "MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Western Laboratories Corp. has at least 6 other 510(k) clearances on record.