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U.S. Department of Health and Human Services

Product Classification

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Device susceptibility test discs, antimicrobial
Regulation Description Antimicrobial susceptibility test disc.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeJTN
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.1620
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Review Criteria for Assessment of Antimicrobial Susceptibility Test Discs [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM094102.pdf] 
Third Party Review
Accredited Persons

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