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U.S. Department of Health and Human Services

Product Classification
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Device culture media, antimicrobial susceptibility test, mueller hinton agar/broth
Regulation Description Culture medium for antimicrobial susceptibility tests.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeJTZ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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		 Ineligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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