510(k) K870958

TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 by Helena Laboratories — Product Code CEF

K870958 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091". The FDA issued a decision of Substantially Equivalent on April 29, 1987. 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.