510(k) K780934

IN VITRO TOBRAMYCIN RIA KIT by Clinical Assays, Inc. — Product Code KLB

K780934 is an FDA 510(k) premarket notification submitted by Clinical Assays, Inc. for the device "IN VITRO TOBRAMYCIN RIA KIT". The FDA issued a decision of Substantially Equivalent on August 14, 1978. The device falls under product code KLB (Radioimmunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Clinical Assays, Inc. has at least 10 other 510(k) clearances on record.