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U.S. Department of Health and Human Services

Product Classification

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Device c3-indirect immunofluorescent solid phase
Regulation Description Complement components immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeKTM
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5240
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
Third Party Review
Accredited Persons
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