LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO

LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO is an FDA 510(k)-cleared medical device (K134013) manufactured by Bio-Rad Laboratories. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 23, 2014. Regulation: 8.