510(k) K953437

OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT by Olympus America, Inc. — Product Code GTQ

K953437 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT". The FDA issued a decision of Substantially Equivalent on October 20, 1995. The device falls under product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent), a Class I device regulated under 21 CFR 866.3720. Olympus America, Inc. has at least 10 other 510(k) clearances on record.