
Serono Diagnostics, Inc.
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LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA is an FDA 510(k)-cleared medical device (K873186) manufactured by Serono Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 28, 1987. Regulation: 8.