
Serono Diagnostics, Inc.
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HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS is an FDA 510(k)-cleared medical device (K862262) manufactured by Serono Diagnostics, Inc.. 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 28, 1986. Regulation: 8.