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U.S. Department of Health and Human Services

Product Classification

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Device culture media, antimicrobial susceptibility test
Regulation Description Culture medium for antimicrobial susceptibility tests.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLKA
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.1700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review
Accredited Persons
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