
Connecticut Diagnostics, Ltd.
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CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN is an FDA 510(k)-cleared medical device (K792339) manufactured by Connecticut Diagnostics, Ltd.. 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 December 5, 1979. Regulation: 8.