
Amersham Corp.
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ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) is an FDA 510(k)-cleared medical device (K893036) manufactured by Amersham Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 1, 1989. Regulation: 8.