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U.S. Department of Health and Human Services

Product Classification
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Device culture media, for isolation of pathogenic neisseria
Regulation Description Culture medium for pathogenic Neisseria spp.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeJTY
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.2410
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 Standard
Third Party Review
Accredited Persons
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