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U.S. Department of Health and Human Services

Product Classification

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Device system, test, fibrin/fibrinogen degradation products for monitoring of colorectal cancer
Regulation Description Tumor-associated antigen immunological test system.
Definition Monitoring cancer patients after therapy for disease progression in conjunction with other diagnostic modalities.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNTY
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.6010
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible