
Gds Technology, LLC
Free shipping on orders over $99 · 30-day returns
KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON is an FDA 510(k)-cleared medical device (K911801) manufactured by Gds Technology, LLC. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 30, 1991. Regulation: 8.