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U.S. Department of Health and Human Services

Product Classification

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Device electrode measurement, blood-gases (pco2, po2) and blood ph
Regulation Description Blood gases (PCO2, PO2) and blood pH test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeCHL
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1120
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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