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U.S. Department of Health and Human Services

Product Classification

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Device system, test, automated, antimicrobial susceptibility, short incubation
Regulation Description Fully automated short-term incubation cycle antimicrobial susceptibility system.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLON
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.1645
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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