
Amersham Corp.
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AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT is an FDA 510(k)-cleared medical device (K912733) 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 July 21, 1991. Regulation: 8.