510(k) K980646

IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES by Instrumentation Laboratory CO — Product Code MQM

K980646 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES". The FDA issued a decision of Substantially Equivalent on May 6, 1998. The device falls under product code MQM (Bilirubin (Total And Unbound) In The Neonate Test System), a Class I device regulated under 21 CFR 862.1113. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.