510(k) K881809

REP LIPO KIT CAT. NO 3180 by Helena Laboratories — Product Code JHO

K881809 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "REP LIPO KIT CAT. NO 3180". The FDA issued a decision of Substantially Equivalent on June 1, 1988. The device falls under product code JHO (Electrophoretic Separation, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Helena Laboratories has at least 10 other 510(k) clearances on record.