
Lkb Instruments, Inc.
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DELFIA(TM) HIGE KIT is an FDA 510(k)-cleared medical device (K871599) manufactured by Lkb Instruments, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 11, 1987. Regulation: 8.