
Amersham Corp.
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AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT is an FDA 510(k)-cleared medical device (K893469) manufactured by Amersham Corp.. 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 August 14, 1989. Regulation: 8.