Indicator, Chemical, Enzymatic, Sterilization Process

FDA product code MTC · Class II (moderate risk) · 21 CFR 880.2800 · General Hospital

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K210481Instant 20s IndicatorMTC · Traditional True Indicating, LLC12/14/2021SE
K962649Sportrol Rapid Sterility IndicatorMTC · Traditional North American Science Assoc., Inc.09/26/1997SE