510(k) K854820

RA 80 EIKEN by Syn-Kit, Inc. — Product Code DHR

K854820 is an FDA 510(k) premarket notification submitted by Syn-Kit, Inc. for the device "RA 80 EIKEN". The FDA issued a decision of Substantially Equivalent on January 17, 1986. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Syn-Kit, Inc. has at least 10 other 510(k) clearances on record.