
Amersham Corp.
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AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT is an FDA 510(k)-cleared medical device (K882907) 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 September 21, 1988. Regulation: 8.