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U.S. Department of Health and Human Services

Product Classification
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Device cytokeratins
Regulation Description Immunoglobulin (light chain specific) immunological test system.
Regulation Medical Specialty Immunology
Review Panel Pathology
Product CodeLYE
Premarket Review Division of Molecular Genetics and Pathology (DMGP)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 866.5550
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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