510(k) K830978

HELENA BIOSTRIP A by Helena Laboratories — Product Code JMA

K830978 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "HELENA BIOSTRIP A". The FDA issued a decision of Substantially Equivalent on May 13, 1983. The device falls under product code JMA (Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)), a Class I device regulated under 21 CFR 862.1095. Helena Laboratories has at least 10 other 510(k) clearances on record.