510(k) K850035

EMPTY SOLUTION TRANSFER CONTAINER by The Healthcare Group Laboratories, Inc. — Product Code KPE

K850035 is an FDA 510(k) premarket notification submitted by The Healthcare Group Laboratories, Inc. for the device "EMPTY SOLUTION TRANSFER CONTAINER". The FDA issued a decision of Substantially Equivalent on June 7, 1985. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. The Healthcare Group Laboratories, Inc. has at least 10 other 510(k) clearances on record.