
Monoclonal Antibodies, Inc.
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SERUM HCG ASSAY is an FDA 510(k)-cleared medical device (K832562) manufactured by Monoclonal Antibodies, 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 September 11, 1983. Regulation: 8.