510(k) K810404

RHEUMATOID FACTORS REFERENCE SERUM by Calbiochem-Behring Corp. — Product Code DHR

K810404 is an FDA 510(k) premarket notification submitted by Calbiochem-Behring Corp. for the device "RHEUMATOID FACTORS REFERENCE SERUM". The FDA issued a decision of Substantially Equivalent on March 11, 1981. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Calbiochem-Behring Corp. has at least 10 other 510(k) clearances on record.