510(k) K953875

CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) by In-Line Diagnostics Corp. — Product Code MQS

K953875 is an FDA 510(k) premarket notification submitted by In-Line Diagnostics Corp. for the device "CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on July 23, 1996. The device falls under product code MQS (System, Hemodialysis, Access Recirculation Monitoring), a Class II device regulated under 21 CFR 876.5820. In-Line Diagnostics Corp. has at least 7 other 510(k) clearances on record.