
Amersham Corp.
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AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA is an FDA 510(k)-cleared medical device (K860252) 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 February 10, 1986. Regulation: 8.