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U.S. Department of Health and Human Services

Product Classification

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Device igm (mu chain specific), antigen, antiserum, control
Regulation Description Immunoglobulin (light chain specific) immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeDAO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5550
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Draft Guidance Document for 510(k) Submission of Immunoglobulins A,G,M,D and E Immunoglobulin System In Vitro Devices [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM094259.pdf] 
Third Party Review
Accredited Persons

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