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U.S. Department of Health and Human Services

Product Classification

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Device calibrator, surrogate
Regulation Description Calibrator.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeJIW
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1150
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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