
Lkb Instruments, Inc.
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LBK 1244 DELFIA HCG KIT is an FDA 510(k)-cleared medical device (K852760) manufactured by Lkb Instruments, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 1985. Regulation: 8.