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U.S. Department of Health and Human Services

Product Classification

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Device a chemical vapor sterilization multivariable chemical indicator
Regulation Description Sterilization process indicator.
Definition A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.
Physical State The device consists of chemicals attached to a non-reactive material surface that react to two or sterilization process parameters.
Technical Method Uses chemical reactions to indicate a pass signal to sterilization parameters that are consistent with identified stated values
Target Area not intended for patient contact
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeQKM
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 880.2800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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