510(k) K922725

TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL by Simplicity Diagnostics, Inc. — Product Code DHR

K922725 is an FDA 510(k) premarket notification submitted by Simplicity Diagnostics, Inc. for the device "TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL". The FDA issued a decision of Substantially Equivalent on October 5, 1992. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Simplicity Diagnostics, Inc. has at least 4 other 510(k) clearances on record.