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U.S. Department of Health and Human Services

Product Classification

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Device indicator, biological sterilization process
Regulation Description Sterilization process indicator.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFRC
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type 510(k)
Regulation Number 880.2800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • FDA Guide for Validation of Biological Indicator Incubation Time
Third Party Review
Accredited Persons

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