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U.S. Department of Health and Human Services

Product Classification
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Device sparse sample pk profile and dosing software
Regulation Description Predictive pulmonary-function value calculator.
Definition To estimate PK profile and dosing calculation.
Physical State Solid
Technical Method Software driven
Target Area Blood
Regulation Medical Specialty Anesthesiology
Review Panel Hematology
Product CodePHY
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 868.1890
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 Not Third Party Eligible
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