
Serono-Baker Diagnostics, Inc.
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SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) is an FDA 510(k)-cleared medical device (K911217) manufactured by Serono-Baker 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 August 15, 1991. Regulation: 8.