
Monoclonal Antibodies, Inc.
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B-CLONE HCG ASSAY is an FDA 510(k)-cleared medical device (K831155) 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 June 1, 1983. Regulation: 8.