510(k) K840319

CAT 15-HEMATOLOGY & PATHOLOGY DEVICE by Imm Enterprises , Ltd. — Product Code HTD

K840319 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "CAT 15-HEMATOLOGY & PATHOLOGY DEVICE". The FDA issued a decision of Substantially Equivalent on March 12, 1984. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800. Imm Enterprises , Ltd. has at least 10 other 510(k) clearances on record.