BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT

BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT is an FDA 510(k)-cleared medical device (K952568) manufactured by Beckman Instruments, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 7, 1995. Regulation: 8.