510(k) K894486

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

K894486 is an FDA 510(k) premarket notification submitted by Biokit USA, Inc. for the device "QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)". The FDA issued a decision of Substantially Equivalent on Oct 24, 1989. The device falls under product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent), a Class I device regulated under 21 CFR 866.3720. Biokit USA, Inc. has 15 other 510(k) clearances on record.