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U.S. Department of Health and Human Services

Product Classification

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Device control, platelet
Regulation Description Hematology quality control mixture.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGJP
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.8625
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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