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U.S. Department of Health and Human Services

Product Classification

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Device lipoprotein, low-density, antigen, antiserum, control
Regulation Description Low-density lipoprotein immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDFC
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5600
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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