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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 Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.1645
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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