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U.S. Department of Health and Human Services

Product Classification

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Device system,test,(ihc),tumor marker,monitoring,bladder cancer
Regulation Description Immunohistochemistry reagents and kits.
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodeNBK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.1860
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
Accredited Persons