510(k) K760036

TEST, LATEX SLIDE, RHEUMATOID FACTOR by Gamma Biologicals, Inc. — Product Code DHR

K760036 is an FDA 510(k) premarket notification submitted by Gamma Biologicals, Inc. for the device "TEST, LATEX SLIDE, RHEUMATOID FACTOR". The FDA issued a decision of Substantially Equivalent on August 3, 1976. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Gamma Biologicals, Inc. has at least 10 other 510(k) clearances on record.