
Simplicity Diagnostics, Inc.
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TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL is an FDA 510(k)-cleared medical device (K970100) manufactured by Simplicity Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 9, 1997. Regulation: 8.