510(k) K964453

REP 3 FLUR SPE-60 KIT by Helena Laboratories — Product Code CEF

K964453 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "REP 3 FLUR SPE-60 KIT". The FDA issued a decision of Substantially Equivalent on December 23, 1996. The device falls under product code CEF (Electrophoretic, Protein Fractionation), a Class I device regulated under 21 CFR 862.1630. Helena Laboratories has at least 10 other 510(k) clearances on record.