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U.S. Department of Health and Human Services

Product Classification

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Device manual antimicrobial susceptibility test systems
Regulation Description Antimicrobial susceptibility test powder.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeJWY
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.1640
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
Recognized Consensus Standards
Guidance Document
Third Party Review
Accredited Persons
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