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U.S. Department of Health and Human Services

Product Classification
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Device kit, assay, estrogen receptor
Regulation Description Immunohistochemistry reagents and kits.
Regulation Medical Specialty Hematology
Review Panel Clinical Chemistry
Product CodeLPJ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type PMA
Regulation Number 864.1860
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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