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U.S. Department of Health and Human Services

Product Classification

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Device solubility, hemoglobin, abnormal
Regulation Description Sickle cell test.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJBB
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.7825
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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