510(k) K131595

EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM by Eurotrol B.V. — Product Code JJY

K131595 is an FDA 510(k) premarket notification submitted by Eurotrol B.V. for the device "EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM". The FDA issued a decision of Substantially Equivalent on July 26, 2013. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Eurotrol B.V. has at least 6 other 510(k) clearances on record.