510(k) K984546

BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK by Hemocleanse, Inc. — Product Code FLD

K984546 is an FDA 510(k) premarket notification submitted by Hemocleanse, Inc. for the device "BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK". The FDA issued a decision of Substantially Equivalent on August 13, 1999. The device falls under product code FLD (Apparatus, Hemoperfusion, Sorbent), a Class II device regulated under 21 CFR 876.5870. Hemocleanse, Inc. has at least 4 other 510(k) clearances on record.