
Serono-Baker Diagnostics, Inc.
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ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) is an FDA 510(k)-cleared medical device (K912318) manufactured by Serono-Baker Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 24, 1991. Regulation: 8.