
Serono-Baker Diagnostics, Inc.
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SR1 (FSH) IMMUNOENZYMETRIC ASSAY is an FDA 510(k)-cleared medical device (K892706) 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 June 8, 1989. Regulation: 8.