STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR is an FDA 510(k)-cleared medical device (K133549) manufactured by Steritec Products Mfg Co, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 2014. Regulation: 8.