510(k) K781501

ENZAC INCUBATOR by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JRG

K781501 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "ENZAC INCUBATOR". The FDA issued a decision of Substantially Equivalent on October 3, 1978. The device falls under product code JRG (Block, Heating), a Class I device regulated under 21 CFR 862.2050. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.