BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)

BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) is an FDA 510(k)-cleared medical device (K972747) manufactured by Propper 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 January 8, 1998. Regulation: 8.