510(k) K935958

CRIT-LINE BLOOD CHAMBER WITH E-BEAM by In-Line Diagnostics Corp. — Product Code KOC

K935958 is an FDA 510(k) premarket notification submitted by In-Line Diagnostics Corp. for the device "CRIT-LINE BLOOD CHAMBER WITH E-BEAM". The FDA issued a decision of Substantially Equivalent on January 19, 1995. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. In-Line Diagnostics Corp. has at least 7 other 510(k) clearances on record.