
Syva Co.
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VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY is an FDA 510(k)-cleared medical device (K926422) manufactured by Syva Co.. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 1, 1993. Regulation: 8.