510(k) K953261

CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM by Shared Systems, Inc. — Product Code DHR

K953261 is an FDA 510(k) premarket notification submitted by Shared Systems, Inc. for the device "CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on August 15, 1995. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Shared Systems, Inc. has at least 4 other 510(k) clearances on record.