510(k) K896271

QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) by Biokit USA, Inc. — Product Code DHR

K896271 is an FDA 510(k) premarket notification submitted by Biokit USA, Inc. for the device "QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)". The FDA issued a decision of Substantially Equivalent on November 8, 1989. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Biokit USA, Inc. has at least 10 other 510(k) clearances on record.