510(k) K893211

REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 by Helena Laboratories — Product Code CEF

K893211 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171". The FDA issued a decision of Substantially Equivalent on June 19, 1989. 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.