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U.S. Department of Health and Human Services

Product Classification

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Device susceptibility test powders, antimicrobial
Regulation Description Antimicrobial susceptibility test powder.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeJTT
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.1640
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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