510(k) K811375

BI-RA SLIDE TEST by Biologics Intl., Inc. — Product Code DHR

K811375 is an FDA 510(k) premarket notification submitted by Biologics Intl., Inc. for the device "BI-RA SLIDE TEST". The FDA issued a decision of Substantially Equivalent on June 12, 1981. The device falls under product code DHR (System, Test, Rheumatoid Factor), a Class II device regulated under 21 CFR 866.5775. Biologics Intl., Inc. has at least 8 other 510(k) clearances on record.