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U.S. Department of Health and Human Services

Product Classification

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Device bromcresol purple dye-binding, albumin
Regulation Description Albumin test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeCJW
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1035
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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