
Boehringer Mannheim Corp.
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ELECSYS CA 125 II is an FDA 510(k)-cleared medical device (K972162) manufactured by Boehringer Mannheim 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 March 17, 1998. Regulation: 8.