Indicator, Chemical, Enzymatic, Sterilization Process
An Enzymatic Chemical Sterilization Process Indicator is a device used to monitor the efficacy of sterilization processes by detecting enzymatic activity that indicates whether sterilization conditions have been achieved, providing quality assurance in healthcare settings. It is FDA Class 2, requiring 510(k) clearance, with product code MTC under 21 CFR 880.2800 in the General Hospital specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MTC
- Device Class
- FDA class 2
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.