510(k) K863238

READS RF TEST KIT FOR IGM RHEUMATOID FACTOR by Biostar Medical Products, Inc. — Product Code DHR

K863238 is an FDA 510(k) premarket notification submitted by Biostar Medical Products, Inc. for the device "READS RF TEST KIT FOR IGM RHEUMATOID FACTOR". The FDA issued a decision of Substantially Equivalent on October 8, 1986. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Biostar Medical Products, Inc. has at least 4 other 510(k) clearances on record.