MTC — Indicator, Chemical, Enzymatic, Sterilization Process Class II

FDA Device Classification

FDA product code MTC covers "Indicator, Chemical, Enzymatic, Sterilization Process", a Class II medical device regulated under 21 CFR 880.2800. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MTC
Device Class
Class II
Regulation Number
880.2800
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K210481true indicatingInstant 20s IndicatorDecember 14, 2021
K962649north american science assocSPORTROL RAPID STERILITY INDICATORSeptember 26, 1997