510(k) K810221

SCRIPPSERA THEUMATOID FACTOR REFER. CNTL by Scripps-Miles, Inc. — Product Code DHR

K810221 is an FDA 510(k) premarket notification submitted by Scripps-Miles, Inc. for the device "SCRIPPSERA THEUMATOID FACTOR REFER. CNTL". The FDA issued a decision of Substantially Equivalent on February 9, 1981. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Scripps-Miles, Inc. has at least 8 other 510(k) clearances on record.